Azurion 7 M12 Patient Tables: Fall Risk from Defective Mattress
Philips Azurion 7 M12 patient tables are recalled due to a mattress defect that could cause patients to fall. Approximately 1,837 units are affected globally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. The mattress defect on a patient table presents a structural hazard—a fall risk—that could result in serious patient injury in a medical setting.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Azurion 7 M12 patient table system. The affected models have catalog numbers 722078, 722223, and 722233, with 722233 distributed outside the United States only.
The recall is due to a defect in the mattress used on the patient table. The mattress defect creates a possibility that patients could fall from the table during medical procedures.
Approximately 1,837 units have been distributed globally, including 337 units in the United States and 1,500 units in countries outside the US. Healthcare providers using this equipment should discontinue use and contact Philips Medical Systems Nederland B.V. for instructions on corrective action or replacement.
The recalled product
- Product
- Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- fall-risk
- structural-defect
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) 722078
- (2) 722223
- (3) 722233 (OUS ONLY)
- UDI-DI: (1) 00884838085251
- (2) 00884838099241
- (3) 00884838116764
- Serial Numbers: (1) 465
- 437
- 438
- 143
- 302
- 559
- 170
- 824
- 626
- 697
- 278
- 491
- 215
- 720
Distribution
Distributed nationwide across the United States.
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