Medical imaging device missing required radiation safety labels
Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall involving missing required safety labels on radiation-emitting equipment. This qualifies as a risk-of-harm product where no illnesses or injuries have been reported. The missing regulatory labels represent non-compliance with FDA electronic product radiation control standards.
Plain-English summary
Philips Healthcare is recalling the DigitalDiagnost C90 medical imaging device. The FDA determined that some systems at customer locations did not have required regulatory labels applied.
Federal regulations require medical devices that emit X-ray radiation to display a Radiation Warning Label (per 21 CFR 1020.30) and an X-ray control certification statement (per 21 CFR 1010.2). Philips identified that approximately 281 units in US nationwide distribution did not have these labels applied.
The missing labels create a regulatory compliance issue on devices that emit radiation. Customers who have DigitalDiagnost C90 systems should verify that both the Radiation Warning Label and X-ray control certification statement are present. If the labels are missing, customers should contact Philips Healthcare to arrange for the labels to be applied to their equipment.
The recalled product
- Product
- DigitalDiagnost C90
- Manufacturer
- Philips Healthcare
- Hazard
- missing-radiation-label
- missing-certification
- regulatory-non-compliance
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)
- DigitalDiagnost C90
Distribution
Distributed nationwide across the United States.
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