Z-0175-2020 Class II Ongoing

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
August 30, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,438 (17,971 US; 4,467 OUS) devices total

Product Description

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

Reason for Recall

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

Distribution Pattern

Worldwide distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, Indonesia, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, Malaysia, MEXICO, MOROCCO, Myanmar, NETHERLANDS, New Zealand, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, Russia, SAUDI ARABIA, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, Thailand, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, Viet Nam, YUGOSLAVIA.

Code Information

1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, 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L13F0816G, C23F16549, D23F1963G, A23F1205G, J13F0174G, C23F1639G; 2. Product Code: 4T, UDI Number (Serial Numbers): Not Applicable (F24T0254G), Not Applicable (F24T0259G), Not Applicable (F24T0264G), Not Applicable (F24T0279G), Not Applicable (A44T4691G), Not Applicable (A44T4713G), Not Applicable (C44T4931G), Not Applicable (D34T2574G), Not Applicable (H34T3263G), Not Applicable (H34T3264G), Not Applicable (H34T3266G), Not Applicable (H34T3267G), Not Applicable (H34T3268G), Not Applicable (H34T3270G), Not Applicable (H34T3272G), Not Applicable (H34T3274G), Not Applicable (M24T1660G), Not Applicable (M24T1661G), Not Applicable (M24T1662G), Not Applicable (M24T1672G), Not Applicable (M24T1710G), Not Applicable (M24T1716G), Not Applicable (M24T1718G), Not Applicable (M24T1721G), Not Applicable (M34T4314G), Not Applicable (M34T4315G), Not Applicable (M34T4316G), Not Applicable (M34T4321G), Not Applicable (M34T4360G), Not Applicable (M34T4368G), Not Applicable (M34T4482G), Not Applicable (M34T4215G), Not Applicable (M34T4216G), Not Applicable (J34T3725G), Not Applicable (J34T3752G), Not Applicable (J34T3755G), Not Applicable (M34T4340G), Not Applicable (G24T0384G), Not Applicable (K24T1151G), Not Applicable (L24T1274G), Not Applicable (L24T1284G), Not Applicable (L24T1377G), Not Applicable (L24T1401G), Not Applicable (L34T4001G), Not Applicable (A44T4739G), Not Applicable (G24T0475G), Not Applicable (A44T4573G), Not Applicable (C34T2261G), Not Applicable (B44T4778G), Not Applicable (F24T0081G), Not Applicable (F24T0292G), Not Applicable (F24T0294G), Not Applicable (F24T0296G), Not Applicable (F24T0297G), Not Applicable (F24T0318G), Not Applicable (F34T2928G), Not Applicable (K24T1003G), Not Applicable (L34T4174G), Not Applicable (F34T3021G), Not Applicable (C34T2336G), Not Applicable (F24T0242G), Not Applicable (L34T4041G), Not Applicable (M34T4479G), Not Applicable (F24T0084G), Not Applicable (G24T0564G), Not Applicable (M24T1736G), Not Applicable (M34T4449G), Not Applicable (M34T4450G), Not Applicable (B34T1952G), Not Applicable (A34T1762G), Not Applicable (F24T0124G), Not Applicable (F24T0241G), Not Applicable (F34T2959G), Not Applicable (J24T0609G), Not Applicable (J24T0826G), Not Applicable (K24T1143G), Not Applicable (K34T3974G), Not Applicable (M34T4381G), Not Applicable (A34T1853G), Not Applicable (B44T4800G), Not Applicable (D44T5014G), Not Applicable (K34T3833G), Not Applicable (K34T3834G), Not Applicable (K34T3837G), Not Applicable (K34T3843G), Not Applicable (K34T3858G), Not Applicable (K34T3859G), Not Applicable (K34T3966G), Not Applicable (M24T1560G), Not Applicable (M24T1665G), Not Applicable (M24T1673G), Not Applicable (M24T1692G), Not Applicable (M34T4413G), Not Applicable (M34T4415G), Not Applicable (M34T4442G), Not Applicable (M34T4443G), Not Applicable (M34T4444G), Not Applicable (M34T4445G), Not Applicable (L34T4036G), Not Applicable (C34T2256G), Not Applicable (K24T1165G), Not Applicable (L24T1309G), Not Applicable (M24T1528G), Not Applicable (C34T2324G), Not Applicable (C34T2326G), Not Applicable (C34T2328G), Not Applicable (C34T2341G), Not Applicable (A34T1825G), Not Applicable (A34T1826G), Not Applicable (A34T1827G), Not Applicable (A34T1829G), Not Applicable (A34T1830G), Not Applicable (A34T1831G), Not Applicable (A34T1832G), Not Applicable (A34T1848G), Not Applicable (A34T1896G), Not Applicable (A34T1899G), Not Applicable (A34T1900G), Not Applicable (A34T1903G), Not Applicable (B34T2033G), Not Applicable (C34T2298G), Not Applicable (C44T4984G), Not Applicable (G24T0512G), Not Applicable (J34T3789G), Not Applicable (J34T3791G), Not Applicable (C34T2275G), Not Applicable (C34T2361G), Not Applicable (C34T2365G), Not Applicable (C34T2378G), Not Applicable (F24T0247G), Not Applicable (J24T0867G), Not Applicable (J24T0873G), Not Applicable (J34T3597G), Not Applicable (J34T3598G), Not Applicable (J34T3604G), Not Applicable (J34T3605G), Not Applicable (J34T3606G), Not Applicable (J34T3628G), Not Applicable (J34T3631G), Not Applicable (J34T3669G), Not Applicable (K34T3871G), Not Applicable (F34T2927G), Not Applicable (M24T1608G), Not Applicable (M24T1647G), Not Applicable (D34T2530G), Not Applicable (D34T2534G), Not Applicable (D34T2538G), Not Applicable (J34T3517G), Not Applicable (J24T0831G), Not Applicable (C34T2265G), Not Applicable (C34T2267G), Not Applicable (F24T0269G), Not Applicable (J34T3816G), Not Applicable (B34T1947G), Not Applicable (B34T1951G), Not Applicable (J24T0846G), Not Applicable (J24T0862G), Not Applicable (J24T0876G), Not Applicable (H34T3437G), Not Applicable (A44T4581G), Not Applicable (B34T1984G), Not Applicable (B34T1989G), Not Applicable (B44T4905G), Not Applicable (B44T4913G), Not Applicable (C44T4930G), Not Applicable (F24T0054G), Not Applicable (F24T0239G), Not Applicable (G24T0414G), Not Applicable (G24T0506G), Not Applicable (G24T0520G), Not Applicable (G24T0521G), Not Applicable (G24T0524G), Not Applicable (H34T3284G), Not Applicable (J24T0738G), Not Applicable (J24T0833G), Not Applicable (J24T0836G), Not Applicable (M24T1668G), Not Applicable (M24T1671G), Not Applicable (D34T2454G), Not Applicable (D34T2535G), Not Applicable (D34T2545G), Not Applicable (F24T0053G), Not Applicable (D44T5027G), Not Applicable (K24T1117G), Not Applicable (K24T1118G), Not Applicable (K24T1190G), Not Applicable (K24T1191G), Not Applicable (K24T1196G), Not Applicable (K24T1197G), Not Applicable (K24T1200G), Not Applicable (B44T4880G), Not Applicable (B44T4882G), Not Applicable (J24T0642G), Not Applicable (J24T0813G), Not Applicable (M24T1569G), Not Applicable (B34T2021G), Not Applicable (M24T1540G), Not Applicable (J34T3601G), Not Applicable (M24T1603G), Not Applicable (M24T1749G), Not Applicable (M34T4339G), Not Applicable (M34T4493G), Not Applicable (M34T4494G), Not Applicable (K34T3968G), Not Applicable (D34T2629G), Not Applicable (B34T2006G), Not Applicable (M24T1609G), Not Applicable (M24T1663G), Not Applicable (A44T4676G), Not Applicable (B34T1991G), Not Applicable (B34T1998G), Not Applicable (B34T1999G), Not Applicable (B34T2105G), Not Applicable (B34T2107G), Not Applicable (B34T2108G), Not Applicable (B34T2109G), Not Applicable (D34T2440G), Not Applicable (H34T3419G), Not Applicable (J24T0704G), Not Applicable (J24T0790G), Not Applicable (J24T0792G), Not Applicable (J24T0799G), Not Applicable (J24T0854G), Not Applicable (J34T3807G), Not Applicable (K34T3839G), Not Applicable (K34T3840G), Not Applicable (K34T3841G), Not Applicable (K34T3844G), Not Applicable (L24T1304G), Not Applicable (F34T3027G), Not Applicable (K34T3920G), Not Applicable (L34T4102G), Not Applicable (L34T4103G), Not Applicable (L34T4104G), Not Applicable (L34T4105G), Not Applicable (L34T4106G), Not Applicable (K24T1214G), Not Applicable (K24T1215G), Not Applicable (K24T1225G), Not Applicable (L24T1362G), Not Applicable (H34T3477G), Not Applicable (K24T1266G), Not Applicable (L34T4005G), Not Applicable (M24T1455G), Not Applicable (F34T2841G), Not Applicable (M34T4432G), Not Applicable (F24T0308G), Not Applicable (F24T0309G), Not Applicable (G24T0417G), Not Applicable (G24T0420G), Not Applicable (J34T3521G), Not Applicable (G24T0462G), Not Applicable (G24T0470G), Not Applicable (B34T1979G), Not Applicable (B34T1986G), Not Applicable (B34T1987G), Not Applicable (L24T1294G), Not Applicable (L24T1303G), Not Applicable (L24T1315G), Not Applicable (H34T3361G), Not Applicable (K24T1193G), Not Applicable (K24T1198G), Not Applicable (B34T2043G), Not Applicable (B34T2047G), Not Applicable (B34T2055G), Not Applicable (B34T2202G), Not Applicable (L24T1391G), Not Applicable (F24T0278G), Not Applicable (F24T0149G), Not Applicable (F24T0211G), Not Applicable (G24T0324G), Not Applicable (H34T3435G), Not Applicable (M24T1512G), Not Applicable (J24T0900G), Not Applicable (L34T4109G), Not Applicable (M34T4446G), Not Applicable (M34T4481G), Not Applicable (M34T4539G), Not Applicable (H34T3441G), Not Applicable (K34T3978G), Not Applicable (B44T4781G), Not Applicable (F34T2978G), Not Applicable (B44T4745G), Not Applicable (B44T4751G), Not Applicable (D34T2470G), Not Applicable (K24T1184G), Not Applicable (A34T1781G), Not Applicable (A34T1784G), Not Applicable (A34T1785G), Not Applicable (A34T1789G), Not Applicable (A34T1791G), Not Applicable (C34T2407G), Not Applicable (J24T0823G), Not Applicable (D34T2509G), Not Applicable (K34T3886G), Not Applicable (K34T3928G), Not Applicable (K34T3960G), Not Applicable (F24T0276G), Not Applicable (B34T2163G), Not Applicable (B44T4783G), Not Applicable (C34T2235G), Not Applicable (F24T0256G), Not Applicable (J24T0671G), Not Applicable (J24T0700G), Not Applicable (J24T0879G), Not Applicable (J24T0884G), Not Applicable (J34T3686G), Not Applicable (J34T3688G), Not Applicable (J34T3689G), Not Applicable (J34T3693G), Not Applicable (K34T3900G), Not Applicable (K34T3902G), Not Applicable (A44T4704G), Not Applicable (A44T4707G), Not Applicable (K24T1033G), Not Applicable (K24T1039G), Not Applicable (A44T4637G), Not Applicable (A44T4639G), Not Applicable (B44T4747G), Not Applicable (F24T0203G), Not Applicable (G34T3207G), Not Applicable (B34T2019G), Not Applicable (D34T2473G), Not Applicable (D34T2475G), Not Applicable (D34T2491G), Not Applicable (D34T2493G), Not Applicable (D34T2495G), Not Applicable (D34T2518G), Not Applicable (D34T2527G), Not Applicable (D34T2541G), Not Applicable (D34T2546G), Not Applicable (D34T2570G), Not Applicable (D34T2602G), Not Applicable (D34T2604G), Not Applicable (D34T2605G), Not Applicable (D34T2606G), Not Applicable (M34T4318G), Not Applicable (M24T1600G), Not Applicable (M24T1700G), Not Applicable (D34T2482G), Not Applicable (D34T2516G), Not Applicable (D34T2573G), Not Applicable (F34T2854G), Not Applicable (F34T2858G), Not Applicable (F34T2863G), Not Applicable (F34T2864G), Not Applicable (F34T2865G), Not Applicable (F34T2867G), Not Applicable (G24T0448G), Not Applicable (K24T1231G), Not Applicable (K24T1239G), Not Applicable (M24T1677G), Not Applicable (M24T1687G), Not Applicable (M24T1706G), Not Applicable (M24T1712G), Not Applicable (C34T2351G), Not Applicable (C34T2372G), Not Applicable (J34T3653G), Not Applicable (H34T3486G), Not Applicable (J34T3681G), Not Applicable (E34T2726G), Not Applicable (E34T2727G), Not Applicable (E34T2729G), Not Applicable (E34T2732G), Not Applicable (E34T2737G), Not Applicable (F24T0288G), Not Applicable (F24T0289G), Not Applicable (F24T0290G), Not Applicable (F24T0291G), Not Applicable (M24T1504G), Not Applicable (M24T1511G), Not Applicable (M24T1555G), Not Applicable (M24T1561G), Not Applicable (M34T4390G), Not Applicable (B44T4909G), Not Applicable (G24T0543G), Not Applicable (G24T0545G), Not Applicable (H24T0594G), Not Applicable (H34T3265G), Not Applicable (A34T1803G), Not Applicable (F24T0271G), Not Applicable (F24T0284G), Not Applicable (F24T0285G), Not Applicable (F24T0298G), Not Applicable (F24T0299G), Not Applicable (F24T0300G), Not Applicable (F24T0301G), Not Applicable (F24T0303G), Not Applicable (F24T0316G), Not Applicable (G24T0484G), Not Applicable (G24T0488G), Not Applicable (G24T0490G), Not Applicable (G24T0499G), Not Applicable (G24T0542G), Not Applicable (J24T0692G), Not Applicable (J24T0709G), Not Applicable (J24T0710G), Not Applicable (J24T0711G), Not Applicable (J24T0712G), Not Applicable (J24T0716G), Not Applicable (J24T0717G), Not Applicable (J24T0718G), Not Applicable (J24T0722G), Not Applicable (J24T0830G), Not Applicable (K24T1004G), Not Applicable (K24T1014G), Not Applicable (K24T1080G), Not Applicable (F24T0236G), Not Applicable (G24T0411G), Not Applicable (B44T4904G), Not Applicable (F24T0130G), Not Applicable (F24T0272G), Not Applicable (F24T0273G), Not Applicable (G24T0529G), Not Applicable (G24T0538G), Not Applicable (J24T0630G), Not Applicable (J24T0651G), Not Applicable (J24T0691G), Not Applicable (J24T0721G), Not Applicable (J24T0723G), Not Applicable (K24T1007G), Not Applicable (K24T1116G), Not Applicable (K24T1119G), Not Applicable (K24T1120G), Not Applicable (K24T1122G), Not Applicable (K24T1123G), Not Applicable (L24TE1JG), Not Applicable (H34T3277G), Not Applicable (B34T2029G), Not Applicable (B34T2203G), Not Applicable (C34T2268G), Not Applicable (C34T2269G), Not Applicable (C34T2281G), Not Applicable (C34T2397G), Not Applicable (F24T0074G), Not Applicable (F24T0077G), Not Applicable (F24T0078G), Not Applicable (F24T0079G), Not Applicable (G24T0468G), Not Applicable (M24T1442G), Not Applicable (M24T1513G), Not Applicable (M34T4452G), Not Applicable (M34T4453G), Not Applicable (A34T1870G), Not Applicable (B34T1942G), Not Applicable (B34T2111G