The Recall Desk
SevereFDA (Devices)·Z-0181-2015·Announced 2014-11-19

Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault

Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.

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/mechanical defect (hazardous movement of the C-arc) that poses a risk of significant injury, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems, Inc. is recalling 22 units of the Allura Xper FD20C Radiological Imaging system. These systems are equipped with software version R8.2.0 and System Code 722028. The devices are intended for use on human patients to perform vascular, cardiovascular, and neurovascular imaging applications, including diagnostic, interventional, and minimally invasive procedures.

The recall is being conducted because a faulty Automatic Motion Controller (AMC) was detected. Specifically, a problem in the Power On Self Test (POST) error handling can result in a hazardous movement of the C-arc system.

The affected systems were distributed in the United States states of Illinois and Tennessee, as well as in Argentina, Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Norway, Saudi Arabia, Switzerland, the United Kingdom, and Viet Nam. Healthcare facilities should contact Philips Medical Systems for further instructions regarding the recall.

The recalled product

Product
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
Affected units
22

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)

  • Allura Xper Software version: R8.2.0

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →