Philips Xper Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 10 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 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 for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems, Inc. is recalling 10 units of the Philips Healthcare Xper vascular system, model 722124. 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 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 specific serial numbers for the affected units are 2653, 2729, 2853, 2885, 2695, 2761, 2670, 2858, 2846, and 2746.
The recalled product
- Product
- Philips Healthcare Xper vascular system Model : 722124 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.
- Hazard
- Affected units
- 10
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 (1)
- S/N: 2653 2729 2853 2885 2695 2761 2670 2858 2846 2746
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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