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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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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America: BrightView Gamma Camera Systems Recalled for Falling Detector Risk

Agency Publication Date: February 2, 2024
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Summary

Philips North America is recalling 464 BrightView, BrightView X, and BrightView XCT gamma camera systems because a internal component failure may cause the heavy detector unit to fall unexpectedly. If the detector falls while positioned below the center of the machine, it can strike a patient, potentially causing serious injuries such as bone fractures, deep cuts, or bruising. All serial numbers for these specific models are affected by this recall, which includes units distributed both across the United States and internationally.

Risk

A component failure within the system can cause the detector to drop suddenly. If a patient's lower limbs are underneath the detector at the time of failure, the impact can cause abrasion, contusion, laceration, or bone fractures, while also causing the medical system to stop operating correctly.

What You Should Do

  1. Identify if your facility uses a Philips BrightView Gamma Camera system by checking the model numbers: BrightView (Model 882480, 453560279781, 453560279791, 453560279811, 453560279801, 2170-3000A, 2170-3001A, 2170-3002A, 2170-3003A), BrightView X (Model 882478, 453560824741, 453560829261), or BrightView XCT (Model 882482, 453560462131, 453560749161).
  2. Confirm your equipment is affected; all serial numbers for the model numbers listed above are included in this recall.
  3. Contact your healthcare provider or Philips North America at 1-800-722-9377 for further instructions regarding the safety of your device and any necessary repairs or inspections.
  4. If you are a patient scheduled for a scan on one of these systems, contact your healthcare provider to discuss the risks and potential impact on your normal system operation.
  5. For additional information or questions, contact the FDA hotline 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 system inspection

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

Affected Products

Product: BrightView, gamma camera system
Model / REF:
882480
453560279781
453560279791
453560279811
453560279801
2170-3000A
2170-3001A
2170-3002A
2170-3003A
Lot Numbers:
All serial numbers affected
Product: BrightView X, gamma camera for SPECT
Model / REF:
882478
453560824741
453560829261
Lot Numbers:
All serial numbers affected
Product: BrightView XCT, gamma camera for SPECT
Model / REF:
882482
453560462131
453560749161
Lot Numbers:
All serial numbers affected

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93767
Status: Active
Manufacturer: Philips North America
Sold By: Authorized medical equipment distributors
Manufactured In: United States
Units Affected: 3 products (302 US; 264 OUS; 56 US; 46 OUS; 106 US; 241 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.