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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 NEDERLAND B.V.: Philips Imaging Systems Recalled Due to Faulty X-Ray Foot Switches

Agency Publication Date: September 14, 2023
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Summary

Philips Medical Systems Nederland B.V. has recalled 19,115 imaging systems, including Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva models. These systems utilize a foot switch that, if damaged, can cause x-ray radiation to fail to start or only initiate intermittently during medical procedures. This failure to operate as intended could disrupt critical diagnostic imaging or surgical guidance. Affected units were distributed worldwide, and users are advised to contact the manufacturer or their healthcare facility's service provider for inspection and support.

Risk

A damaged foot switch can prevent the medical professional from initiating x-ray radiation when needed, potentially delaying critical medical procedures or resulting in incomplete diagnostic information. This malfunction poses a risk to patients undergoing time-sensitive interventions where continuous or immediate imaging is required.

What You Should Do

  1. Identify if your facility uses any of the following Philips systems: Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, or MultiDiagnost-Eleva.
  2. Check the model number of your system against the list of affected models, which include: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, and 722400.
  3. Inspect the foot switch component of your imaging system for any visible signs of physical damage or wear that may impact its functionality.
  4. If you experience intermittent x-ray initiation or if the foot switch fails to work entirely, contact your facility's biomedical engineering department or Philips service personnel immediately.
  5. Contact Philips Medical Systems for further instructions or technical support regarding the repair or replacement of the foot switch component.
  6. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer support and service inspection

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

Affected Products

Product: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Model / REF:
708032
708034
708036
708037
708038
722001
722002
722003
722005
722006
722008
722010
722011
722012
722013
722015
722019
722020
722022
722023
722025
722026
722027
722028
722029
722031
722033
722035
722038
722039
722058
722059
722063
722064
722065
722066
722067
722068
722078
722079
722221
722222
722223
722224
722225
722226
722227
722228
722280
722400

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92901
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Philips Medical Systems; Medical device distributors
Manufactured In: Netherlands
Units Affected: 19,115 systems
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.