Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the...
FDA Device Recall #Z-1045-2016 — Class II — January 7, 2016
Recall Summary
| Recall Number | Z-1045-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 7, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular Us Sales, Llc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 2 within US; 247 OUS |
Product Description
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
Reason for Recall
MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down.
Distribution Pattern
Worldwide Distribution - US including AZ and MO. Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.
Lot / Code Information
Catalog Number 1180.19F0; Serial numbers 00003 and 00004.
Other Recalls from Maquet Cardiovascular Us Sales, Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0632-2021 | Class II | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; ... | Nov 20, 2020 |
| Z-0633-2021 | Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS ... | Nov 20, 2020 |
| Z-0443-2021 | Class II | Blood Monitoring Unit (BMU 40), model no. 70104... | Sep 30, 2020 |
| Z-0133-2021 | Class II | Yuno II Mobile Operating Table - Product Usage:... | Sep 24, 2020 |
| Z-0132-2021 | Class II | Yuno Mobile Operating Table - Product Usage: In... | Sep 24, 2020 |
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.