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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.: Medical Imaging Systems Recalled for Falling Parts Risk

Agency Publication Date: September 18, 2024
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Summary

Philips Medical Systems is recalling approximately 16,768 medical imaging systems worldwide, including Azurion, Allura, and Integris models, due to a defect in the cable hose carrier. The plastic components or bolts holding the cable hose carrier may break, which can cause heavy parts of the equipment or the cable hose itself to detach and fall during use. This voluntary recall affects multiple series of diagnostic and interventional systems manufactured in the Netherlands and distributed globally.

Risk

If the plastic carrier or mounting bolts fail, heavy components of the cable hose assembly can fall unexpectedly onto a patient or healthcare provider, potentially causing serious impact injuries or interrupting critical medical procedures.

What You Should Do

  1. Identify if your facility uses any of the following Philips systems: Azurion 3, 5, or 7 (models 722063 through 722282), Allura Xper FD series (models 722001 through 722059), INTEGRIS Allura (models 722016 through 722044), or MultiDiagnost Eleva (models 708032 through 708038).
  2. Check the specific model numbers and UDI-DI codes against the affected list, such as Azurion 7 M20 (01)00884838110571(21) or Allura Xper FD20 (01)00884838059054(21).
  3. Contact your healthcare provider or Philips Medical Systems Nederland B.V. immediately to schedule a professional inspection and determine if your specific unit requires repair or part replacement.
  4. Follow all safety instructions provided by the manufacturer in the official notification letter regarding continued use of the equipment until it is inspected.
  5. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for potential detachment issues

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

Affected Products

Product: Azurion 7 M20
Model / REF:
722282
722234
722224
722079
UPC Codes:
00884838110571
00884838116771
00884838099258
00884838085268
Lot Numbers:
All serial numbers
Product: Azurion 5 M20
Model / REF:
722281
722228
UPC Codes:
00884838110564
00884838099234
Lot Numbers:
All serial numbers
Product: Azurion 7 B20
Model / REF:
722236
722226
722068
UPC Codes:
00884838116801
00884838099272
00884838085367
Lot Numbers:
All serial numbers
Product: Azurion 7 B12
Model / REF:
722235
722225
722067
UPC Codes:
00884838116788
00884838099265
00884838085350
Lot Numbers:
All serial numbers
Product: Azurion 7 M12
Model / REF:
722233
722223
722078
UPC Codes:
00884838116764
00884838099241
00884838085251
Lot Numbers:
All serial numbers
Product: Azurion 5 M12
Model / REF:
722227
UPC Codes:
00884838099227
Lot Numbers:
All serial numbers
Product: Azurion 3 M15
Model / REF:
722222
722064
UPC Codes:
00884838099210
00884838085282
Lot Numbers:
All serial numbers
Product: Azurion 3 M12
Model / REF:
722221
722063
UPC Codes:
00884838099203
00884838085275
Lot Numbers:
All serial numbers
Product: Allura Xper FD20/15 OR Table
Model / REF:
722059
UPC Codes:
00884838059122
Lot Numbers:
All serial numbers
Product: Allura Xper FD20/15
Model / REF:
722058
UPC Codes:
00884838059115
Lot Numbers:
All serial numbers
Product: Allura Xper FD20/20
Model / REF:
722038
UPC Codes:
00884838054226
Lot Numbers:
All serial numbers
Product: Allura Xper FD20 OR Table
Model / REF:
722035
722023
722015
UPC Codes:
00884838054240
Lot Numbers:
All serial numbers
Product: Allura Xper FD20/10
Model / REF:
722029
UPC Codes:
00884838054219
Lot Numbers:
All serial numbers
Product: Allura Xper FD20
Model / REF:
722028
722012
722006
UPC Codes:
00884838054202
00884838059054
00884838055513
Lot Numbers:
All serial numbers
Product: Allura Xper FD10/10
Model / REF:
722027
722011
722005
UPC Codes:
00884838054196
00884838080805
Lot Numbers:
All serial numbers
Product: Allura Xper FD10
Model / REF:
722026
722010
722003
UPC Codes:
00884838054189
00884838059030
00884838059191
Lot Numbers:
All serial numbers
Product: Allura Xper FD20 Biplane
Model / REF:
722013
722008
UPC Codes:
00884838059061
Lot Numbers:
All serial numbers
Product: INTEGRIS Allura 15-12 (biplane)
Model / REF:
722044
Lot Numbers:
All serial numbers
Product: Integris CV Cesar-Powerpack-Visub-Nicol
Model / REF:
722030
Lot Numbers:
All serial numbers
Product: INTEGRIS Allura 9 (biplane)
Model / REF:
722021
Lot Numbers:
All serial numbers
Product: Integris Allura 9
Model / REF:
722018
Lot Numbers:
All serial numbers
Product: Integris H5000 F / Allura 9F
Model / REF:
722017
Lot Numbers:
All serial numbers
Product: Integris H5000 C / Allura 9C
Model / REF:
722016
Lot Numbers:
All serial numbers
Product: MultiDiagnost Eleva with Flat Detector
Model / REF:
708038
708037
708034
Lot Numbers:
All serial numbers
Product: MultiDiagnost Eleva
Model / REF:
708036
708032
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95256
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Philips medical equipment distributors; Direct sales to hospitals and clinics
Manufactured In: Netherlands
Units Affected: 4 products (7091 units; 9318 units; 250 units; 109 units)
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.