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.
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: 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.
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.
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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