Z-1874-2019 Class I Terminated
FDA device recall Z-1874-2019 was initiated by Hamilton Medical AG on March 25, 2019 and is designated Class I. Reason for recall: New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patien… The recall status is terminated (terminated June 3, 2024). Affected quantity: 4338 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2019
- Initiation Date
- March 25, 2019
- Termination Date
- June 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4338 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT, and RI. And (International Distribution): AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IT, MT, NL. NO, PL.PT, RO, SE, SI, SK, TR, HR. AGO, ARE, ARM, AUS, AZE, BGD, BHR , BLR, BOL, BRA, CAN, CHL, CHN, COL, CRI, DOM, DZA, ECU, EGY, EST, HKG, IDN, IND, IRQ, ISR, JOR, JPN, KAZ, KOR, KWT, LBN, LBY, LKA, LVA, MAR, MDA, MDV, MEX, MNG, MYS, NPL, NZL, OMN, PAK, PAN, PER, PHL, PRI, PSE, QAT, RUS, SAU, SGP, SUR, SYR, THA, TUN, TWN, UKR, URY, USA, VEN, VNM, YEM, and ZAF.