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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 DuraDiagnost X-Ray Systems Recalled for Falling Component Risk

Agency Publication Date: April 11, 2025
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Summary

Philips North America Llc is recalling 83 units of the Philips DXR DuraDiagnost 4.1 and DuraDiagnost Release 4 stationary X-ray systems. These systems are being recalled because the collimator—a heavy component of the X-ray machine—can fall if it was not installed correctly during initial setup. No injuries have been reported, but the company is contacting affected medical facilities to inspect the equipment and ensure the component is securely attached. These units were distributed to hospitals and clinics across several U.S. states and internationally.

Risk

If the collimator is incorrectly installed, it could detach and fall from the machine. This poses a significant risk of impact injuries to patients or healthcare providers who are positioned beneath the X-ray tube during medical procedures.

What You Should Do

  1. The recalled products are the Philips DXR System DuraDiagnost 4.1 (REF 712203) and the Philips DXR System DuraDiagnost Release 4 (REF 712214) stationary X-ray systems.
  2. Identify if your system is affected by checking the model reference (REF) and serial number on the device labels. For DuraDiagnost 4.1, affected serial numbers include 220025, 210023, 220171, 230103, and 230152.
  3. For DuraDiagnost Release 4 systems, check the serial number on the device label. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device. Contact Philips or your medical equipment distributor to arrange for a technician to inspect the system and perform any necessary corrections to the installation.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

Your Remedy Options

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

Affected Products

Product: Philips DXR System, DuraDiagnost 4.1 Stationary X-Ray System
Model / REF:
712203
Serial Numbers:
220025
210023
220171
230103
230152
UDI:
00884838095205

Recall number Z-1553-2025

Product: Philips DXR System, DuraDiagnost Rel. 4 Stationary X-Ray System
Model / REF:
712214
Serial Numbers:
SN170009
SN170010
SN180072
SN180020
200037
SN160061
SN180075
200089
SN180045
SN160096
UDI:
00884838064751

Recall number Z-1554-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96435
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Philips medical equipment distributors
Manufactured In: United States
Units Affected: 2 products (83 units)
Distributed To: Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, Wisconsin

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 · 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.