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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips Medical Systems Quadrature Body Coils Recalled for Loose Seals

Agency Publication Date: May 15, 2025
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Summary

Philips Medical Systems Nederland B.V. is recalling 797 Quadrature Body Coils (QBC) used in various MRI systems, including the Enterprise and Intera series. The adhesive that holds the coil's seal in place can fail, causing the seal to become loose and exposing sharp edges that may come into contact with patients. No injuries have been reported, but the defect was identified as a safety risk during scanning procedures.

Risk

If the QBC seal becomes loose during a scan, it can create sharp edges that may cause skin abrasions, bruises, lacerations, tissue injury, or hair entanglement. These injuries could occur if the patient comes into direct contact with the compromised component during the imaging process.

What You Should Do

  1. The recalled products are Philips Quadrature Body Coils (QBC) used with Enterprise 1.5T, various Intera MRI models (0.5T to 3.0T), and SmartPath to dStream upgrade systems.
  2. Check the model number (REF) on your medical device label; affected models include the Enterprise, Intera, and SmartPath series. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Philips or your authorized distributor to arrange for a return, replacement, or a corrective fix for the seal adhesive.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Enterprise 1.5T
Model / REF:
781145
Serial Numbers:
All serial numbers

Recall #: Z-1770-2025; 34 units affected.

Product: Intera 0.5T Standard
Model / REF:
781101
Serial Numbers:
All serial numbers

Recall #: Z-1771-2025; 14 units affected.

Product: Intera 1.0T Omni/Stellar
Model / REF:
781102
Serial Numbers:
All serial numbers

Recall #: Z-1772-2025; 37 units affected.

Product: Intera 1.0T Power/Pulsar
Model / REF:
781103
Serial Numbers:
All serial numbers

Recall #: Z-1773-2025; 26 units affected.

Product: Intera 1.5T
Model / REF:
781195
781295
Serial Numbers:
All serial numbers

Recall #: Z-1774-2025; 376 units affected.

Product: Intera 1.5T Explorer/Nova Dual
Model / REF:
781108
Serial Numbers:
All serial numbers

Recall #: Z-1775-2025; 12 units affected.

Product: Intera 1.5T Master/Nova
Model / REF:
781106
Serial Numbers:
All serial numbers

Recall #: Z-1776-2025; 103 units affected.

Product: Intera 1.5T Omni/Stellar
Model / REF:
781104
Serial Numbers:
All serial numbers

Recall #: Z-1777-2025; 26 units affected.

Product: Intera 1.5T Power/Pulsar
Model / REF:
781105
Serial Numbers:
All serial numbers

Recall #: Z-1778-2025; 121 units affected.

Product: Intera 1.5T R11
Model / REF:
781170
Serial Numbers:
All serial numbers

Recall #: Z-1779-2025; 23 units affected.

Product: Intera 3.0T Quasar Dual
Model / REF:
781150
Serial Numbers:
All serial numbers

Recall #: Z-1780-2025; 12 units affected.

Product: Intera CV
Model / REF:
781107
Serial Numbers:
All serial numbers

Recall #: Z-1781-2025; 6 units affected.

Product: SmartPath to dStream for 1.5T
Model / REF:
782146
Serial Numbers:
All serial numbers

Recall #: Z-1782-2025; 3 units affected.

Product: SmartPath to dStream for 3.0T
Model / REF:
782145
Serial Numbers:
All serial numbers

Recall #: Z-1783-2025; 4 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96728
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Medical facilities; Authorized Philips medical distributors
Manufactured In: Netherlands
Units Affected: 14 products (34 units (32 US, 2 OUS); 14 units (All OUS); 37 units (3 US, 34 OUS); 26 units (All OUS); 376 units (37 US, 339 OUS); 12 units (2 US, 10 OUS); 103 units (37 US, 66 OUS); 26 units (7 US, 19 OUS); 121 units (51 US, 70 OUS); 23 units (10 US, 13 OUS); 12 units (5 US, 7 OUS); 6 units (4 US, 2 OUS); 3 units OUS; 4 units OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.