Recall Z-1296-2021— Getinge Group Logistics America, LLC
Class II · Ongoing
Class II FDA medical device recall by Getinge Group Logistics America, LLC, initiated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Operating Table System. Reason: 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..
- Recalling firm
- Getinge Group Logistics America, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-02-11
- Firm location
- Wayne, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.