MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to...
FDA Device Recall #Z-1622-2013 — Class II — April 26, 2013
Recall Summary
| Recall Number | Z-1622-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular Us Sales, Llc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 13 Tables; 24 Extension devices |
Product Description
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
Reason for Recall
MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released,
Distribution Pattern
Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
Lot / Code Information
YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
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.