Getinge Usa Sales Inc Recall 91018
Description: Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Getinge Usa Sales Inc Recall 91018 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0239-2023 |
| Event ID | 91018 |
| Event Description | Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN |
| Product Type | Devices |
| 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). |
| Quantity | 5 US; 1008 OUS |
| Recall 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. |
| Device Classification | 20221123 |
| Device 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 |
| Center Classification Date | 20221115 |
| Recall Initiation Date | 20221014 |
| Recalling Firm | Getinge Usa Sales Inc |
| Initial Notification | Letter |
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