Philips recalls Allura patient table mattress due to fall hazard
Philips is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.
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: FDA Class I recalls require a minimum severity score of 4 per the scoring rubric. The mattress defect creates a potential risk of patient falls.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20/15 patient table mattress (catalog number 722058) due to a defect in the mattress that creates a possibility of patients falling from the table.
This recall affects 302 units distributed worldwide. In the United States, 69 units are affected. An additional 233 units have been distributed internationally to numerous countries.
Customers with affected equipment should contact Philips Medical Systems for information about remedial actions. Equipment can be identified by catalog number 722058 and UDI-DI 00884838059115.
The recalled product
- Product
- Allura Xper FD20/15; Catalog numbers: 722058
- 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 number: 722058
- UDI-DI: 00884838059115
- Serial Numbers: 172
- 337
- 178
- 249
- 22
- 202
- 279
- 254
- 285
- 71
- 186
- 82
- 85
- 162
- 138
- 24
- 365
- 203
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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