Recall Z-0239-2023— Getinge Usa Sales Inc

Name: FDA recall Z-0239-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-14

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-10-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN. Reason: The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle..

Recalling firm: Getinge Usa Sales Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-10-14
Firm location: Wayne, NJ, United States

Product description

Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

Reason for recall

The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.