TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagn...

FDA Device Recall #Z-2314-2012 — Class II — July 27, 2012

Recall Summary

Recall Number Z-2314-2012
Classification Class II — Moderate risk
Date Initiated July 27, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Quality Electrodynamics LLC
Location Mayfield Village, OH
Product Type Devices
Quantity 17 units

Product Description

TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.

Reason for Recall

On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

Distribution Pattern

Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany

Lot / Code Information

QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.

Other Recalls from Quality Electrodynamics LLC

Recall # Classification Product Date
Z-0037-2020 Class II TxRx Knee 15 Coil 1.5T QED part number: Q70000... Aug 20, 2019
Z-0033-2020 Class II TxRx CP Extremity Coil 3T QED part number: Q70... Aug 20, 2019
Z-0035-2020 Class II TxRx 15CH Knee Coil 3T QED part number: Q70000... Aug 20, 2019
Z-0031-2020 Class II TxRx 15Ch Knee Coil 3T QED part number:Q700000... Aug 20, 2019
Z-0032-2020 Class II TxRx 15CH Knee Coil 1.5T QED part number:Q7000... Aug 20, 2019

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.