Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 16 Allura Xper cardio 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 is classified as FDA Class II and involves a structural defect (ceiling suspension falling) that poses a risk of significant injury, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems, Inc. is recalling 16 units of the Allura Xper cardio systems, model 722123. The recall is due to a defect in the monitor ceiling suspension system, which may fall. The affected systems are intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures.
The affected units were distributed worldwide, including in the United States, Canada, Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, South Africa, Spain, Switzerland, and the United Kingdom. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips Healthcare Xper cardio systems Model : 722123 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 and…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 16
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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