Philips Healthcare DigitalDiagnost X-ray Systems Recalled for Image Acquisition Failures
Philips Healthcare is recalling 160 DigitalDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, resulting in failed image acquisition.
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, but the source text explicitly states no injuries or illnesses have been reported. The hazard is a functional failure (image acquisition) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Healthcare is recalling 160 units of the DigitalDiagnost stationary X-ray system. The recall affects software versions 4.0.4, 4.1.2, and 4.1.3. The devices were distributed nationwide to specific states, including AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH, and PA.
The recall is due to a defect where the detector may signal that it is ready for acquisition when it is actually not. This malfunction results in the failure to properly acquire the X-ray image. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Philips Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips Healthcare DigitalDiagnost stationary X-ray system
- Manufacturer
- Philips Healthcare
- Hazard
- Affected units
- 160
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 (3)
- software version - 4.0.4
- 4.1.2
- 4.1.3.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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