Medical X-Ray Systems Missing Required Radiation Warning Labels
Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.
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: FDA Class II labeling compliance issue with no reported illnesses or injuries. The recall addresses missing radiation warning labels on X-ray equipment; while radiation hazards are serious, the issue is one of proper application of required safety labels rather than equipment malfunction.
Plain-English summary
Philips Healthcare is recalling ProxiDiagnost N90 multi-functional X-ray and fluorography systems (R/F systems). A total of 281 systems distributed nationwide in the United States are subject to this recall.
Some of these systems were found to lack required warning labels mandated by FDA Electronic Product Radiation Control performance standards. Specifically, affected units are missing the Radiation Warning Label required under 21 CFR 1020.30(j) and the X-ray control certification statement required under 21 CFR 1010.2. These labels ensure that healthcare personnel and patients are informed of radiation hazards.
Healthcare facilities operating ProxiDiagnost N90 systems should contact Philips Healthcare to verify that their equipment has the required radiation warning labels and certification statements properly displayed. Systems should not be operated without these mandatory safety labels in place.
The recalled product
- Product
- ProxiDiagnost N90 is multi-functional general R/F systems.
- Manufacturer
- Philips Healthcare
- Affected units
- 281
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)
- ProxiDiagnost N90
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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