The Recall Desk
SevereFDA (Devices)·Z-0354-2016·Announced 2015-12-09

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.

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 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 and
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 →