Philips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems because electronic markers may be placed at the wrong anatomical position when images are moved between views.
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. The hazard involves potential mislabeling of anatomical positions in diagnostic images, which is a significant quality issue but does not involve direct physical injury, death, or high-risk pathogens, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems with Digital Panels. The recall was initiated because a software issue may cause electronic markers to be placed at the wrong anatomical position in the resulting image when an operator moves an image to another view.
The affected units were distributed nationwide to facilities in Arkansas, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Vermont, and Wisconsin. The recall applies to all units of this specific model.
Healthcare facilities should contact Philips Healthcare Inc. for instructions on how to resolve the issue. Patients who have had X-rays taken with these systems should consult their healthcare provider if they have concerns about the accuracy of their images.
The recalled product
- Product
- Mobile Diagnostic X-Ray System with Digital Panel
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 220
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 units ***
Distribution
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