SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR sy...
FDA Device Recall #Z-1024-2016 — Class II — July 6, 2015
Recall Summary
| Recall Number | Z-1024-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 6, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Electronics North America Corporation |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 5672 |
Product Description
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Reason for Recall
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
Distribution Pattern
US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Chile China Colombia Columbia Congo, Democratic Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jersey Jordan Kazakhstan Kenya Korea, Republic of Kuwait Kyrgyzstan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Malta Martinique Mauritius Mexico Monaco Mongolia Morocco Mozambique Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian territory, occupied Panama Papua New Guinea Peru Philippines Poland Portugal Puerto Rico Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Venezuela Viet Nam Yemen Zimbabwe
Lot / Code Information
4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051
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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.