Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
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 is an FDA Class I recall. FDA Class I classifications indicate potential for serious adverse health consequences, meeting the Critical severity threshold.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20 fluoroscopy system patient table due to an issue with the mattress that could result in patients falling from the table during use.
The recall affects units with catalog numbers 722006, 722012, and 722028. A total of 5,029 units have been distributed worldwide—1,566 in the United States and 3,463 internationally.
The FDA has classified this recall as Class I.
The recalled product
- Product
- Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- patient-fall
- mattress-problem
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) 722006
- (2) 722012
- (3) 722028
- UDI-DI: (1) No UDI
- (2) 00884838059054
- (3) 00884838054202
- Serial Numbers: (1) 2013
- 2155
- 1473
- 2110
- 1364
- 2268
- 172
- 2324
- 1637
- 1881
- 2229
- 2533
- 2158
- 1774
Distribution
Distributed nationwide across the United States.
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