Home / Recalls / Getinge Group Logistics America, LLC / Z-1296-2021

Z-1296-2021 Class II Ongoing

Recalled by Getinge Group Logistics America, LLC — Wayne, NJ

FDA device recall Z-1296-2021 was initiated by Getinge Group Logistics America, LLC on February 11, 2021 and is designated Class II. Reason for recall: There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positionin… The recall status is ongoing. Affected quantity: 4288 units.

Recall Details

Product Type: Devices
Report Date: March 31, 2021
Initiation Date: February 11, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4288 units

Product Description

Operating Table System

Reason for Recall

There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.

Distribution Pattern

Domestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Lybia, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom, Uzbekistan, Venezuela, Vietnam and Yemen.

Code Information

Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.