The Recall Desk
HighFDA (Devices)·Z-0352-2016·Announced 2015-12-09

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.

What this means for you

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 thr
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Equipment
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.

See all 9 products in this recall →

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Same hazard · falling object

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