Surgical Operating Table Recalled Due to Patient Fall Risk
Philips Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.
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 recall designation reflects a reasonable probability of serious adverse health consequences. Although no injuries or deaths are reported in the source text, a patient fall from a surgical operating table during a procedure presents a significant risk of serious harm.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20 Biplane OR Table (catalog numbers 722020 and 722025) due to a defect in the patient table mattress that creates a risk of patient falls during surgical procedures.
Three units have been distributed worldwide: 2 in the United States and 1 outside the United States across numerous countries. A patient fall from the surgical table during a procedure poses a risk of serious injury. Medical facilities with this equipment should contact Philips Medical Systems Nederland B.V. for instructions on remediation.
The recalled product
- Product
- Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
- 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 (7)
- Catalog numbers: (1) 722020
- (2) 722025
- UDI-DI: (1) No UDI
- (2) 00884838059108
- Serial Numbers: (1) 6
- (2) 2
- 3.
Distribution
Distributed nationwide across the United States.
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