Medical imaging device patient table mattress may cause patient falls
Philips is recalling Allura Xper FD10 imaging devices because the patient table mattress may not securely hold patients during procedures, creating a fall hazard. The recall affects 2,274 units worldwide, including 459 in the U.S.
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 is an FDA Class I recall, which by the rubric criteria should never score below 4. Although no illnesses or injuries have been reported, the FDA classification indicates a serious potential hazard. A patient falling from an imaging device table could cause serious injury.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Allura Xper FD10 imaging devices due to a hazard involving the patient table mattress. The mattress may not adequately secure patients, creating a possibility that patients could fall from the table during procedures.
The recall affects 2,274 units of the Allura Xper FD10 worldwide, including 459 in the United States and 1,815 distributed to other countries. The recalled devices are identified by catalog numbers 722003, 722010, or 722026, with specific affected serial numbers documented by the FDA.
This is a Class I recall, indicating a serious potential hazard to patient safety. Healthcare facilities should verify their equipment status and contact the manufacturer for information regarding this recall.
The recalled product
- Product
- Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- patient-fall
- mattress-defect
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) 722003
- (2) 722010
- (3) 722026
- UDI-DI: (1) No UDI
- (2) 00884838059030
- (3) 00884838054189
- Serial Numbers: (1) 285
- 1634
- 1349
- 1153
- 1154
- 1472
- 803
- 1694
- 1599
- 1460
- 1138
- 1532
- 940
- 1214
Distribution
Distributed nationwide across the United States.
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