Philips Azurion 5 M12 Patient Table Recalled for Fall Risk
Philips Medical Systems is recalling Azurion 5 M12 imaging tables due to a mattress defect that could allow patients to fall from the table.
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: Classified as FDA Class I, which mandates severity level 4 according to the rubric. Although no injuries have been reported, the potential for patient harm from falls on a medical imaging table during clinical use justifies this elevated classification.
Plain-English summary
Azurion 5 M12 is a medical imaging table manufactured by Philips Medical Systems Nederland B.V. The product is distributed under catalog numbers 722227 and 722231.
The mattress attached to the patient table presents a risk of patient falls due to a defect. No injuries have been reported to date, though the potential hazard warrants the recall.
A total of 282 units have been distributed worldwide, including 9 in the United States and 273 outside the US across more than 100 countries.
The recalled product
- Product
- Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- fall-risk
- mattress-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) 722227
- (2) 722231(OUS ONLY)
- UDI-DI: (1) 00884838099227
- (2) 00884838116740
- Serial Numbers: (1) 276
- 238
- 264
- 63
- 88
- 135
- 261
- 19
- 62
- 83
- 171
- 191
- 240
- 133
- 100
- 93
Distribution
Distributed nationwide across the United States.
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