Philips Allura Xper Patient Table Mattress Defect Fall Risk
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall received FDA Class I classification, which is listed in the rubric criteria for Critical severity. The mattress defect creates a direct fall risk that could result in patient injury during medical procedures.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10C patient examination table (Catalog number 722001, Serial Number 283) due to a mattress defect. The defect creates a possibility that patients may fall from the table during use.
The affected device has been distributed worldwide, including throughout the United States and numerous other countries. Healthcare facilities should verify whether they operate this specific device and serial number.
This is a Class I recall, which indicates a serious hazard to patient safety. Facilities with this device should contact the manufacturer, Philips Medical Systems Nederland B.V., for further instructions.
The recalled product
- Product
- Allura Xper FD10C; Catalog number: 722001
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- Affected units
- 1
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 (3)
- Catalog number: 722001
- UDI-DI: no UDI
- Serial Number: 283
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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