Philips Xper Vascular System Monitor Ceiling Suspension Recall
Philips Medical Systems is recalling 22 Allura Xper vascular 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 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: The recall involves a structural defect (falling ceiling suspension) that poses a significant risk of injury, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Philips Medical Systems, Inc. is recalling 22 units of the Philips Healthcare Xper vascular systems (Model 722134, R7.6). The recall is due to a defect where the monitor ceiling suspension system may fall.
The affected systems are intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures. The recall covers units distributed in the United States and internationally, including 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 specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 22
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.
See all 9 products in this recall →Related recalls
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