Philips Allura Xper FD20C Recalled for Faulty Motion Controller
Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.
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 involves a structural/mechanical defect in a medical device that can result in hazardous movement, posing a significant risk of injury to patients or operators, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Philips Medical Systems, Inc. is recalling two units of the Allura Xper FD20C system with software version R8.2.0. These medical imaging systems are intended for vascular, cardiovascular, and neurovascular applications.
The recall is due to a problem in the Power On Self Test (POST) error handling within the Automatic Motion Controller (AMC). This fault can result in hazardous movement of the C-arc system.
The affected units were distributed in the United States (Illinois and Tennessee) and internationally 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. Users should contact Philips Medical Systems for further instructions.
The recalled product
- Product
- Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and…
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Imaging System
- Affected units
- 2
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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