Philips Allura Xper Fluoroscopy Device Patient Table Mattress Fall Risk
Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.
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: This recall is classified FDA Class I, the agency's most serious classification for medical devices, which requires a minimum severity score of 4 (Severe). No deaths or reported serious injuries are mentioned in the source material.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling certain Allura Xper FD10/10 fluoroscopy imaging devices used in medical facilities.
The recall addresses a possibility that the patient table mattress could allow patients to fall during procedures, posing a safety hazard.
The affected devices have catalog numbers 722005, 722011, or 722027. A total of 590 units were distributed worldwide, including 141 units in the United States and 449 units internationally.
Healthcare facilities with affected devices should contact the manufacturer for guidance and corrective action regarding the mattress issue.
The recalled product
- Product
- Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
- 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) 722005
- (2) 722011
- (3) 722027
- UDI-DI: (1) No UDI
- (2) 00884838059047
- (3) 00884838054196
- Serial Numbers: (1) 361
- 212
- 321
- 435
- 285
- 384
- 388
- 340
- 343
- 399
- 392
- 565
- 355
- 367
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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