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.
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: 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.
- Hazard
- patient-fall
- mattress-issue
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.
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