Philips Medical Imaging Systems Recalled for Measurement Export Error
Philips is recalling 157 medical imaging systems because a software option prevents correct export of measurement data to external destinations.
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, but the source text explicitly states no illnesses or injuries are reported, and the hazard is a data export error rather than a direct physical risk, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Electronics North America Corporation is recalling 157 units of specific medical imaging systems, including the Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, and Azurion 7 M20. These devices are intended for use on human patients for vascular, cardiovascular, and neurovascular imaging applications, as well as diagnostic and interventional procedures.
The recall is due to a software issue where measurements performed using the QA Basic Measurement tool are not correctly exported to external DICOM destinations when the downscale option is used on the Allura R9 system or Azurion R1.1 system. The affected units were distributed worldwide and nationwide in the United States.
Healthcare facilities should contact Philips for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging Systems
- Affected units
- 157
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 (6)
- 7220063
- 722064
- 22065
- 722066
- 722078
- 722079
Distribution
Distributed nationwide across the United States.
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