Philips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk
Philips Medical Systems is recalling nine Allura Xper Series units 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 structural defect where a component may fall, posing a risk of harm, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems, Inc. is recalling nine units of the Allura Xper Series, including models FD10, FD10/10, FD20, FD21, FD22, FD23, FD24, and FD25. These systems are intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures.
The recall is being conducted because the monitor ceiling suspension system may fall. The affected units were distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and South America.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 9
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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