Agency classClass IIOur severity:High FDA (Devices)·Z-2669-2016·Announced 2016-09-07

Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk

Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.

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 3/5 (High).

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 is classified as FDA Class II. The hazard involves a component failure rate increase in a medical device, which poses a risk of harm but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).

Plain-English summary

Philips Electronics North America Corporation is recalling 1,536 Allura Xper medical imaging systems, including various FD10, FD20, and biplane models, as well as UNIQ systems. The recall is due to an increase in the failure rate of certain low-voltage DC power supplies (DCPS) installed in these devices.

The affected devices were distributed nationwide in the United States and in numerous international locations, including Canada, Australia, and various countries in Europe, Asia, and the Americas. The specific hazard identified is the increased likelihood of the power supply failing, which could impact the operation of the medical imaging equipment.

Healthcare facilities and users of these devices should contact Philips to arrange for inspection and repair of the affected power supplies. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product: Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: component-failure
Affected units: 1,536

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 with release R8.2

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

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

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · component failure