The Recall Desk
HighFDA (Devices)·Z-0347-2016·Announced 2015-12-09

Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk

Philips Medical Systems is recalling five Allura BiPlane X-ray 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.

Plain-English summary

Philips Medical Systems, Inc. is recalling five units of the Allura BiPlane Series (Model 722013) X-ray imaging systems. The affected models include the Allura Xper FD20 BIPLANE R7.6, R7.7, R7.8, R7.9, and R7.10. These systems are intended for cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures.

The recall is being issued because the monitor ceiling suspension system may fall. The affected 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 source text does not specify a remediation method or report any injuries or illnesses associated with this recall.

The recalled product

Product
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The Allur
Affected units
5

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 →