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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.: Azurion 7M20 X-Ray Systems Recalled for Unpredictable Stand Movement

Agency Publication Date: September 4, 2024
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Summary

Philips Medical Systems Nederland B.V. has recalled 927 Philips Azurion 7M20 Interventional Fluoroscopic X-Ray Systems equipped with the FlexArm ceiling-mounted stand. The motorized stand, which moves along a ceiling rail, may move inconsistently or stop working entirely because grease or anti-corrosion oil is leaking from internal bearings onto the rail. This leakage reduces the necessary friction between the rail and the drive wheel, making the equipment difficult to position correctly during medical procedures. Consumers should contact Philips or their healthcare facility's technical department to arrange for an inspection and repair.

Risk

If the ceiling-mounted stand moves unexpectedly or becomes stuck during a procedure, it could delay critical medical treatment or result in the equipment colliding with staff or patients. This mechanical failure is caused by excessive lubrication on the ceiling rails which prevents the friction wheel from maintaining a steady grip.

What You Should Do

  1. Identify if your facility uses the Philips Azurion 7M20 system with FlexArm ceiling-mounted system, specifically Model Numbers 722079 or 722224.
  2. Check the serial number of your device against the affected list, which includes 927 units such as 261, 277, 1257, 2770, 1316, 3067, 703615, 2929, 2675, and many others listed in the official recall notice.
  3. Verify the Unique Device Identifiers (UDI-DI) on the product labeling: (01)00884838085268 or (01)00884838099258.
  4. If you notice the longitudinal movement of the FlexArm stand is not smooth or feels inconsistent, stop using the motorized movement and contact your internal technical service or Philips representative immediately.
  5. Contact Philips Medical Systems Nederland B.V. via their customer service channels or your dedicated account representative to schedule a service visit for bearing inspection and rail cleaning.
  6. For additional information or questions regarding this recall, 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 correction/repair

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

Affected Products

Product: Philips Azurion 7M20 Interventional Fluoroscopic X-Ray System (Model 722079)
Model / REF:
722079
UPC Codes:
00884838085268
00884838099258
Lot Numbers (429):
261
277
1257
2770
1316
3067
703615
2929
2675
139
159
703335
1018
703497
2727
1170
2957
266
1160
766
2156
1615
1637
1651
1657
1925
643
370
637
331
2793
1405
588
2241
2325
2326
2327
1278
740
747
851
852
1040
88
447
2278
1164
866
1063
1459
Product: Philips Azurion 7M20 Interventional Fluoroscopic X-Ray System (Model 722224)
Model / REF:
722224
UPC Codes:
00884838085268
00884838099258
Lot Numbers (429):
261
277
1257
2770
1316
3067
703615
2929
2675
139
159
703335
1018
703497
2727
1170
2957
266
1160
766
2156
1615
1637
1651
1657
1925
643
370
637
331
2793
1405
588
2241
2325
2326
2327
1278
740
747
851
852
1040
88
447
2278
1164
866
1063
1459

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95148
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Philips medical equipment distributors
Manufactured In: Netherlands
Units Affected: 927 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.