Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET acc...
FDA Device Recall #Z-0390-2017 — Class II — October 5, 2016
Recall Summary
| Recall Number | Z-0390-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Medical Systems USA |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 9 Units (US) 141 Units (OUS) |
Product Description
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Reason for Recall
Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
Lot / Code Information
600525A0
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| Z-0977-2024 | Class II | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BI... | Jan 8, 2024 |
| Z-0978-2024 | Class II | BO-RF-32-USA RotaFlow Centrifugal Pump with SOF... | Jan 8, 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.