The Recall Desk
SevereFDA (Devices)·Z-0351-2016·Announced 2015-12-09

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 throm
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Equipment
Hazard
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.

See all 9 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems, Inc.

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Same hazard · falling object

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