Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
- Company
- Getinge Usa Sales Inc
- Recall Initiated
- October 14, 2022
- Posted
- November 15, 2022
- Recall Number
- Z-0239-2023
- Quantity
- 5 US; 1008 OUS
- Firm Location
- Wayne, NJ
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.
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 (GR), Hungary (HU), Indonesia (ID), Israel (IL), Italy (IT), Japan (JP), Jordan (JO), Kuwait (KW), Lithuania (LT), Luxembourg (LU), Mexico (MX), Montenegro (ME), Morocco (MA), Netherlands (NL), Norway (NO), Pakistan (PK), Peru (PE), Poland (PL), Portugal (PT), Romania (RO), Russia (RU), Saudi Arabia (SA), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), Tunisia (TN), Turkey (TR), United Arab Emirates (AE), United Kingdom (GB), Yemen (YE).
Lot / Code Info
No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851
Root Cause
Equipment maintenance
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.