Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels
Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.
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 3/5 (High).
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: Radiation equipment with missing mandated safety warning labels represents a risk-of-harm situation, but no injuries or illnesses have been reported. The issue is regulatory non-compliance on a Class II medical device.
Plain-English summary
Philips Healthcare is recalling 281 CombiDiagnost R90 multi-functional radiography/fluoroscopy (R/F) systems distributed nationwide in the United States.
Some systems at customer locations do not have the required FDA safety labels applied. Specifically, the units lack a Radiation Warning Label (required by 21 CFR 1020.30) and an X-ray control certification statement (required by 21 CFR 1010.2). These labels are mandated under FDA Electronic Product Radiation Control performance standards.
Healthcare facilities that have received this equipment should contact Philips Healthcare immediately to obtain and apply the missing labels to their systems. No injuries or adverse events related to this issue have been reported to the FDA.
The recalled product
- Product
- CombiDiagnost R90 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)
- CombiDiagnost R90
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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