Philips Allura Xper FD20/20 Imaging Table Mattress Recall
Philips is recalling 114 units of the Allura Xper FD20/20 imaging table due to mattress defects that could cause patients to fall. 33 units are in the US; 81 are internationally distributed.
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 classification establishes a minimum severity score of 4 per the rubric. The hazard represents a significant patient injury risk from potential falls without reported injuries having occurred.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 114 units of the Allura Xper FD20/20 imaging table (Catalog number 722038), a medical imaging device used in healthcare facilities.
The mattress used on the patient table poses a risk that patients could fall from the table during use. The FDA has issued a Class I recall for this device.
The recalled units have been distributed globally, including 33 in the United States and 81 internationally. Healthcare facilities with affected devices should contact Philips Medical Systems Nederland B.V. for further instructions.
The recalled product
- Product
- Allura Xper FD20/20; Catalog numbers: 722038
- 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: 722038
- UDI-DI: 00884838054226
- Serial Numbers: 39
- 63
- 42
- 55
- 67
- 99
- 60
- 71
- 141
- 115
- 7
- 78
- 108
- 106
- 167
- 118
- 130
- 49
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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