Recall Z-1296-2021
Getinge Group Logistics America, LLC · initiated February 11, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Operating Table System
Codes / lots: 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.
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.
FDA-determined cause: Device Design
Action taken
In February, 2021, Maquet GmbH/Getinge, will issue an Urgent Medical Device Correction notice to customers via FedEx 2 Day Delivery for the Magnus 1180 Operating Table due to a potential for hydraulic leakage to occur at the inclination function which may result in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning. If this were to occur, it may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
Details
- Recall number
- Z-1296-2021
- Initiated
- February 11, 2021
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- 4288 units
- Distribution
- 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…
- Recalling firm
- Getinge Group Logistics America, LLC, Wayne, NJ