PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 23, 2022 Initiated: October 14, 2022 #Z-0239-2023

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.

Details

Recalling Firm
Getinge Usa Sales Inc
Units 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 (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).
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN. Recalled by Getinge Usa Sales Inc. Units affected: 5 US; 1008 OUS.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0239-2023.