Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects
Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defects described are software-related functional errors (stitching interruption, wrong baseline) rather than immediate physical hazards like electrical shock or radiation leakage, fitting the Moderate severity criteria for non-critical software defects.
Plain-English summary
Philips Medical Systems GmbH is recalling specific versions of DigitalDiagnost software (4.1.x and 4.2.x) used with A Stationary X-ray Systems. The recall involves 829 units distributed worldwide, including the United States, Canada, and numerous other countries.
The recall is due to a defect where the stitching run on the SkyPlate detector is interrupted intermittently, and stitching with SkyPlate aborts after the first image. Additionally, the system software CD contains the wrong baseline. These issues may affect the functionality and accuracy of the X-ray imaging system.
Healthcare facilities and users of the affected models (712027, 712028, 712029, 712031, 712032, 712033, 712224, 712225, 712226, 712227, and 712228) should check their serial numbers against the list provided in the official recall notice. Users should contact Philips Medical Systems for instructions on how to resolve the software issues.
The recalled product
- Product
- Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
- Manufacturer
- Philips Medical Systems Gmbh, DMC
- Affected units
- 829
Distribution
Distributed nationwide across the United States.
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