Agency classClass IOur severity:Severe FDA (Devices)·Z-1142-2025·Announced 2025-02-26

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.

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 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.
Category: Medical Device — Diagnostic Imaging Equipment
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.

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 →

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · patient fall