Philips Azurion 3 M15 Patient Tables Recalled for Patient Fall Risk
Philips recalls Azurion 3 M15 imaging tables due to mattress defects that could cause patients to fall from the examination table.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, the highest classification for medical devices. Per the severity rubric, Class I recalls must score at least 4 (Severe). The mattress defect creates a direct patient safety hazard—risk of falls on a medical examination table.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Azurion 3 M15 patient examination table due to a mattress defect that creates a possibility of patients falling from the table.
A total of 735 units have been distributed worldwide: 42 in the United States and 693 internationally. The affected catalog numbers are 722064, 722222, and 722280 (catalog 722280 distributed outside the United States only).
This is a Class I FDA recall due to the patient safety risk created by the mattress defect.
The recalled product
- Product
- Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 (20)
- Catalog numbers: (1) 722064
- (2) 722222
- (3) 722280(OUS ONLY)
- UDI-DI: (1) 00884838085282
- (2) 00884838099210 (3) No UDI
- Serial Numbers: (1) 267
- 335
- 260
- 261
- 209
- 238
- 64
- 229
- 218
- 314
- 291
- 201
- 270
- 258
- 341
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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