Reported Mar 31, 2021 · Ongoing
Operating Table System
Getinge Group Logistics America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Group Logistics America, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Operating Table System
- Lot codes and dates
- Part Number
118001A0118001B0118001B1118001B2118001B3118001B4118001C0118001D0
- UDI code
0404676803150004046768031531040467680407000404676808835104046768088061040467681247520404676803155504046768031579
- Serial Number
1 34021 10281 12641 4013 741 812 11592 - 762
- Part Number
- Amount recalled
- 4288 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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