Agency classClass IIOur severity:Severe FDA (Devices)·Z-0924-2017·Announced 2017-02-01

Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

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 defect (loose screws) in a medical device that could cause uncontrolled rotation, 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 Electronics North America Corporation is recalling two units of the Allura Xper FD20 R8.2 722028 medical device. This equipment is intended for cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures such as PTCA, stent placement, atherectomies, pacemaker implantations, and electrophysiology (EP).

The recall is due to a production error where screws were not tightened to the specified torque. These screws may come loose from the C-arm shaft, which could cause the C-arm to rotate in an uncontrolled manner.

The affected units were distributed in Washington (US) and internationally in China, Spain, Korea, Republic of, and Germany. Users of these devices should contact Philips for further instructions regarding the recall and necessary corrective actions.

The recalled product

Product: Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
uncontrolled-rotation
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)

1000

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Philips Electronics North America Corporation 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 4 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · structural defect