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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 North America: Quadrature Body Coil (QBC) Recalled for Sharp Edges and Seal Failure

Agency Publication Date: February 1, 2024
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Summary

Philips North America is recalling several models of the Quadrature Body Coil (QBC) used in various Achieva, Ingenia, and Intera MRI systems, affecting approximately 2,141 units worldwide. The adhesive seal on these coils can fail, which causes the seal to become loose and create sharp edges that may come into contact with patients during a scan. This defect can lead to physical injuries such as skin abrasions, cuts, bruises, or hair entanglement.

Risk

If the coil seal fails and detaches during a medical scan, the resulting sharp edges can directly contact the patient's skin, potentially causing lacerations, tissue injury, or hair entanglement in the loose adhesive and components.

What You Should Do

  1. Identify if your MRI system uses an affected Quadrature Body Coil by checking the Model (REF) numbers against your equipment documentation. Affected models include: Achieva 1.5T (781196, 781343, 781296), Achieva 1.5T Conversion (781346, 781283), Achieva 3.0T (781277, 781177, 781278, 781344, 781345), Achieva XR (781153, 781253), Ingenia 1.5T CX (781262, 781261), Ingenia 3.0T CX (781271, 782105), Intera 1.5T Achieva Nova (781172), Intera 1.5T Achieva Nova-Dual (781173), and Intera Achieva 1.5T Pulsar (781171).
  2. Check for specific Unique Device Identifiers (UDI) on your equipment, such as 00884838055292, 00884838004108, 00884838068469, 00884838009806, 00884838004139, 00884838068445, 00884838068438, 00884838068452, 00884838098312, 00884838095076, 00884838098886, 00884838095083, 00884838098909, or 00884838105805.
  3. If you are a patient scheduled for an MRI, you may contact your healthcare provider to confirm if their equipment is affected and if any precautions are being taken.
  4. Healthcare facilities should contact Philips North America immediately to discuss inspection of the seals and to arrange for necessary corrective actions or repairs.
  5. Contact Philips North America at their Cambridge, Massachusetts headquarters or via their official customer support channels for further instructions regarding this voluntary recall.
  6. For additional questions or to report an injury, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and potential repair/inspection

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Achieva 1.5T Quadrature Body Coil
Model / REF:
781196
781343
781296
UPC Codes:
00884838055292
00884838004108
Product: Achieva 1.5T Conversion Quadrature Body Coil
Model / REF:
781346
781283
UPC Codes:
00884838068469
00884838009806
Product: Achieva 1.5T Initial system Quadrature Body Coil
Model / REF:
781178
781346
Product: Achieva 3.0T Quadrature Body Coil
Model / REF:
781277
781177
781278
781344
781345
UPC Codes:
00884838004139
Product: Achieva XR Quadrature Body Coil
Model / REF:
781153
781253
Product: Ingenia 1.5T CX Quadrature Body Coil
Model / REF:
781262
781261
UPC Codes:
00884838068445
00884838068438
Product: Ingenia 3.0T CX Quadrature Body Coil
Model / REF:
781271
782105
UPC Codes:
00884838068452
00884838098312
Product: Intera 1.5T Achieva Nova Quadrature Body Coil
Model / REF:
781172
Product: Intera 1.5T Achieva Nova-Dual Quadrature Body Coil
Model / REF:
781173
Product: Intera Achieva 1.5T Pulsar Quadrature Body Coil
Model / REF:
781171
Product: SmartPath to dStream for 1.5T Quadrature Body Coil
Model / REF:
781260
782112
UPC Codes:
00884838095076
00884838098886
Product: SmartPath to dStream for XR and 3.0T Quadrature Body Coil
Model / REF:
781270
782113
782129
UPC Codes:
00884838095083
00884838098909
00884838105805

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93787
Status: Active
Manufacturer: Philips North America
Sold By: medical equipment distributors; Philips direct sales
Manufactured In: United States
Units Affected: 12 products (119 US; 1,807 OUS; 7 US; 137 OUS; 23 US; 51 OUS; 75 US; 442 OUS; 23 US, 20 OUS; 0 US; 146 OUS; 1 US; 347 OUS; 12 US; 45 OUS; 4 US; 17 OUS; 12 US; 25 OUS; 37 US; 735 OUS; 21 US; 265 OUS)
Distributed To: Nationwide
Agency Last Updated: May 7, 2025

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.

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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.