FDA recall Z-0239-2023

Getinge Usa Sales Inc · Class II · device

Product

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.

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).

Key facts

Status
Ongoing
Initiation date
2022-10-14
Report date
2022-11-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2023