Philips CombiDiagnost R90 R1.1 Diagnostic Imaging System Recall: Missing Certification Label
Philips is recalling 25 CombiDiagnost R90 R1.1 diagnostic imaging systems nationwide due to missing FDA certification labels required for regulatory compliance.
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: Missing FDA certification label is a labeling compliance issue without reported injuries or illnesses. Classified as FDA Class II, the hazard is documentation-related rather than a functional safety risk.
Plain-English summary
Philips North America is recalling 25 CombiDiagnost R90 R1.1 diagnostic imaging systems due to missing FDA certification labels. The recall also affects related models, ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 R.1.0.
The recalled systems are missing certification labels required by the Food and Drug Administration. This is an FDA Class II recall issued due to the compliance issue involving missing regulatory labels.
The affected systems were distributed throughout the United States. Serial numbers identified in this recall include 10001071, 10001072, 10001086, 10001087, and 10001114.
The recalled product
- Product
- CombiDiagnost R90 R1.1
- Manufacturer
- Philips North America
- Affected units
- 25
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 (5)
- REF number: 709031 Serial Number: 10001071
- 10001072
- 10001086
- 10001087
- 10001114
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America 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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