Recall Z-0239-2023 ยท FQO Table, Operating-Room, Ac-Powered
Getinge Usa Sales Inc
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
| Date | Nov 15, 2022 (initiated Oct 14, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Equipment maintenance |
| Action | 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. |
| Quantity | 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 (HR), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.