Philips Azurion 5 M20 tables recalled due to patient fall risk
Philips is recalling Azurion 5 M20 imaging tables worldwide due to a mattress defect that could cause patients to fall from the table. This FDA Class I recall involves 632 units.
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's Class I classification requires a minimum severity rating of Severe. Although no injuries have been reported, the potential for patient falls from a medical imaging table represents a serious patient safety hazard.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Azurion 5 M20 patient imaging tables due to a defect in the patient table mattress that creates a risk of patient falls.
The recall affects 632 units: 77 in the United States and 555 distributed overseas. The affected devices carry catalog numbers 722228, 722232 (overseas only), and 722281 (overseas only). Specific serial numbers for each affected device are listed in the FDA recall notice.
The FDA has classified this as a Class I recall. Healthcare facilities that operate these devices should verify whether they have affected units by checking their serial numbers against the recall list provided by the FDA and contact Philips Medical Systems for further guidance.
The recalled product
- Product
- Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (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) 722228
- (2) 722232(OUS ONLY)
- (3) 722281 (OUS ONLY)
- UDI-DI: (1) 00884838099234
- (2) 00884838116757
- (3) no UDI
- Serial Numbers: (1) 522
- 187
- 328
- 113
- 205
- 204
- 273
- 180
- 61
- 523
- 132
- 149
- 48
- 79
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.
See all 20 products in this recall →Related recalls
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