Reported Feb 12, 2025 · Ongoing
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
(1) | Azurion 3 M15 System Code |
722222 | 722064 (2) |
722280 | (3) |
- Lot codes and dates
- UDI
(1) 722064 00884838085282(21)(2) 722222 00884838099210(21)(3) 722280 00884838103276(21)
- UDI
- Amount recalled
- 42 units US; 661 units OUS
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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