The Recall Desk
ModerateFDA (Devices)·Z-0022-2015·Announced 2014-10-15

Philips Integris Allura 15-12 Fluoroscopy System Recalled for Standard Non-Compliance

Philips is recalling one Integris Allura 15-12 Fluoroscopy x-ray system in Florida because it failed to comply with a Federal standard.

What this means for you

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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems, Inc. is recalling one unit of the Integris Allura 15-12 Fluoroscopy x-ray system. The recall was initiated after field service testing revealed that the device failed to comply with a Federal standard.

The affected unit is identified by Model Number Integris Allura 15-12 and Serial Number 16741023. The device was distributed in the United States to Florida.

This is an FDA Class II recall. No specific injuries or illnesses have been reported in the source text. Healthcare facilities should contact Philips for instructions on how to address the non-compliance.

The recalled product

Product
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Equipment
Hazard

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)

  • Model Number: Integris Allura 15-12 Serial Number: 16741023

Distribution

Distributed in 1 state:

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