Operating room table recalled due to mattress-related patient fall risk
Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.
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: FDA Class I classification for a medical device defect involving patient fall risk during operative procedures. Per the severity rubric, FDA Class I recalls require a minimum score of 4. No specific injuries, hospitalizations, or deaths are reported in the source.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20 OR Table due to a defect in the mattress that poses a risk of patients falling from the table. The recalled units carry catalog numbers 722023 and 722035, with corresponding serial numbers 175 and 208.
Two units have been identified and distributed worldwide, including to the United States and numerous international locations. The mattress defect creates a patient safety risk during operative procedures.
Healthcare facilities with affected equipment should contact Philips Medical Systems for remediation guidance. The FDA has classified this as a Class I recall due to the serious patient safety implications.
The recalled product
- Product
- Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- fall-risk
- 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 (6)
- Catalog numbers: (1) 722023
- (2) 722035
- UDI-DI: (1) 00884838059085
- (2) 00884838054240
- Serial Numbers: (1) 175
- (2) 208.
Distribution
Distributed nationwide across the United States.
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