Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
FDA Device Recall #Z-0239-2023 — Class II — October 14, 2022
Recall Summary
| Recall Number | Z-0239-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 14, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Getinge Usa Sales Inc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 5 US; 1008 OUS |
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.
Distribution Pattern
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 Information
No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851
Other Recalls from Getinge Usa Sales Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1074-2025 | Class I | Vaporizer Sevoflurane, Quik-Fil. Model Number: ... | Jan 15, 2025 |
| Z-0462-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0463-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0458-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0460-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.