Philips Digital Diagnost Radiographic System Recalled for Image Rotation Errors
Philips is recalling 360 Digital Diagnost systems because images may rotate in the wrong direction, causing electronic side markers to be misplaced.
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 does not report any hospitalizations, injuries, or deaths. The hazard involves potential misplacement of electronic markers, which is a functional defect without reported physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Healthcare Inc. is recalling 360 units of the Digital Diagnost Stationary radiographic system. The recall involves systems equipped with Eleva software version 3.0.x. These devices were distributed nationwide in the United States and internationally to numerous countries including Argentina, Australia, Canada, Germany, Japan, and the UK.
The recall is due to a software defect where images may rotate in the wrong direction if an operator selects a non-default image rotation or if a rotation is preset in the examination database. When an operator manually rotates the image back to correct the orientation, any programmed electronic side markers also rotate and may end up in the wrong position within the image.
This issue affects medical imaging accuracy and marker placement. The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the affected software version.
The recalled product
- Product
- Philips Digital Diagnost Stationary radiographic system
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 360
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)
- All Digital Diagnost systems with Eleva software version 3.0.x
Distribution
Distributed nationwide across the United States.
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