The Recall Desk
HighFDA (Devices)·Z-3165-2024·Announced 2024-09-25

Philips Azurion X-ray Systems: Cable Hose Carrier Detachment Risk

Philips recalls Azurion X-ray imaging systems due to potential cable hose carrier detachment from broken plastic or bolts, which may cause parts to fall and create injury risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall. The source describes a potential mechanical hazard (cable carrier detachment due to broken components) that may result in injury, but no actual illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling multiple models of Azurion X-ray imaging systems due to a potential hazard with the cable hose carrier.

The cable hose carrier may detach due to broken plastic and/or bolts. When this occurs, parts of the cable hose may fall or drop, potentially resulting in injury to patients, operators, or personnel near the equipment.

The recall affects approximately 7,091 units distributed nationwide and worldwide, including Canada. Affected models include Azurion 3, 5, and 7 series systems in multiple configurations (B12, B20, M12, M15, M20).

Healthcare facilities should contact Philips Medical Systems Nederland B.V. for guidance on addressing this issue with their equipment.

The recalled product

Product
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azu
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging Equipment
Hazard
  • cable-hose-detachment
  • parts-falling
  • injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 2. 722281 Azurion 5 M20 (01)00884838110564(21)
  • 3. 722236 Azurion 7 B20 (01)00884838116801(21)
  • 4. 722235 Azurion 7 B12 (01)00884838116788(21)
  • 5. 722234 Azurion 7 M20 (01)00884838116771(21)
  • 6. 722233 Azurion 7 M12 (01)00884838116764(21)
  • 7. 722228 Azurion 5 M20 (01)00884838099234(21)
  • 8. 722227 Azurion 5 M12 (01)00884838099227(21)
  • 9. 722226 Azurion 7 B20 (01)00884838099272(21)
  • 10. 722225 Azurion 7 B12 (01)00884838099265(21)
  • 11. 722224 Azurion 7 M20 (01)00884838099258(21)
  • 12. 722223 Azurion 7 M12 (01)00884838099241(21)
  • 13. 722222 Azurion 3 M15 (01)00884838099210(21)
  • 14. 722221 Azurion 3 M12 (01)00884838099203(21)
  • 15. 722079 Azurion 7 M20 (01)00884838085268(21)
  • 16. 722078 Azurion 7 M12 (01)00884838085251(21)
  • 17. 722068 Azurion 7 B20 (01)00884838085367(21)
  • 18.722067 Azurion 7 B12 (01)00884838085350(21)
  • 19. 722064 Azurion 3 M15 (01)00884838085282(21)
  • 20. 722063 Azurion 3 M12 (01)00884838085275(21) All serial numbers

Distribution

Distributed nationwide across the United States.

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