Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1066-2016·Announced 2016-03-16

Philips Allura Xper X-Ray Systems Recalled for Fluoroscopy Failure

Philips is recalling 196 Allura Xper X-ray systems because they may display a 'Fluoro failed' error message when initiating fluoroscopy.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error ('Fluoro failed') without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Electronics North America Corporation is recalling 196 units of the Allura Xper X-ray systems, specifically those with product codes 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, and 722059, equipped with release R8.2.16. These devices are intended for cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures.

The recall was initiated because users may encounter a 'Fluoro failed' user message upon initiating fluoroscopy. This issue affects the functionality of the imaging system during use.

The affected devices were distributed nationwide in the United States in the states of AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, and WV, as well as in Canada. Healthcare facilities should contact Philips Electronics North America Corporation for further instructions regarding the recall.

The recalled product

Product: Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — X-Ray Imaging
Hazard: functional-failure
Affected units: 196

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 (12)

Product Codes: 722026
722027
722028
722029
722033
722034
722035
722036
722038
722039
722058
722059 systems with release R8.2.16

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · Philips Electronics North America Corporation

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