The Recall Desk
HighFDA (Devices)·Z-1089-2025·Announced 2025-02-12

Philips Azurion 5 M12 imaging system: finger entrapment risk during tabletop repositioning

Philips Azurion 5 M12 patient imaging systems pose a finger entrapment hazard during manual tabletop repositioning. Operators and service personnel risk finger injury from the longitudinal guiding rails.

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: Class II FDA recall for a risk-of-harm medical device where no illnesses or injuries have been reported. This fits the High severity criterion for risk-of-harm products without reported harm.

Plain-English summary

The Azurion 5 M12 patient imaging system, manufactured by Philips Medical Systems Nederland B.V., is subject to a safety recall due to a finger entrapment hazard. During manual repositioning of the patient tabletop, fingers can become trapped between the longitudinal guiding rails and the tabletop, creating a risk of finger injury.

Both tilt and non-tilt versions of the patient table are affected. The hazard applies to operators and service personnel who manually reposition the tabletop during clinical or maintenance procedures.

Approximately 6 units have been distributed in the United States, with 246 units distributed internationally. The FDA has classified this as a Class II recall.

The recalled product

Product
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging System
Hazard
  • finger-entrapment
  • crush-injury

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 (2)

  • UDI: (1) 722227 00884838099227(21)
  • (2) 722231 00884838116740(21)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category