FDA-Device2022-11-23Class II

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

Getinge Usa Sales Inc

Hazard

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.

Sold states

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).

Affected count

5 US; 1008 OUS

Manufactured in

1 Geoffrey Way, N/A, Wayne, NJ, United States

Products

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

Official notice

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

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