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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Philips Medical Systems, Inc.
- 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
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.
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