Azurion 7 M20 Patient Tables Recalled for Patient Fall Risk
Philips recalls Azurion 7 M20 patient tables due to a mattress defect that could cause patients to fall. Approximately 1,480 units in the US and 2,741 units overseas are affected.
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: The FDA has classified this as a Class I recall, which requires a minimum severity score of 4 per the rubric. Patient falls from medical equipment tables represent a serious potential hazard, even though no incidents have been reported in the source material.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Azurion 7 M20 patient table in the United States and internationally. The recalled units are identified by catalog numbers 722079, 722224, 722234, and 722282, with 4,221 units affected globally: 1,480 in the United States and 2,741 in other countries. A comprehensive list of affected serial numbers is available through the FDA.
The recall is due to a defect in the mattress used on the patient table that creates a possibility of patients falling from the table during use. The FDA has classified this as a Class I recall, indicating a serious potential hazard to patient safety.
Healthcare facilities with affected units should contact the manufacturer or refer to the FDA recall notice for specific instructions and verification of which serial numbers are affected.
The recalled product
- Product
- Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Patient Table
- Hazard
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) 722079
- (2) 722224
- (3) 722234
- UDI-DI: (1) 00884838085268
- (2) 00884838099258
- (3) 00884838116771
- Serial Numbers: (1) 942
- 948
- 702
- 703455
- 703457
- 703465
- 703904
- 45
- 1316
- 709
- 710
- 711
- 713
- 60
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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