Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling five units of the Allura BiPlane Series (Model 722013) X-ray imaging systems. The affected models include the Allura Xper FD20 BIPLANE R7.6, R7.7, R7.8, R7.9, and R7.10. These systems are intended for cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures.
The recall is being issued because the monitor ceiling suspension system may fall. The affected units were distributed worldwide, including in the United States, Canada, Australia, and several other countries.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not specify a remediation method or report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Philips Medical Systems, Inc. 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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