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

FDA device recall Z-0239-2023 · posted 2022-11-15 · Open, Classified

Recall details

Recalling firm

Getinge Usa Sales Inc

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.

Action taken

On October 14, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were provided with extra precautions to take in order to continue use of the device. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, 8AM - 6PM ET.

Root cause

Equipment maintenance

Status

Open, Classified

Product code

FQO

Quantity affected

5 US; 1008 OUS

Distribution

Worldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN. The countries of Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Bulgaria (BG), Canada (CA), China (CN), Croatia (H

Date initiated

2022-10-14

Date posted

2022-11-15

Location

Wayne, NJ