Diagnostic Imaging Systems Missing FDA Certification Label
Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves an FDA Class II device with a documentation compliance issue—missing required FDA certification labeling. No illnesses, injuries, deaths, or device failures have been reported. The hazard is purely regulatory documentation, not a functional or safety defect.
Plain-English summary
Philips North America has issued a recall of 25 diagnostic imaging systems (ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 R.1.0 and R1.1 models) due to a compliance issue: the systems are missing a certification label required by the Food and Drug Administration (FDA).
The affected systems were distributed nationwide in the United States. Healthcare facilities or individuals in possession of these systems should contact Philips North America for information about obtaining the required certification label or other remedial actions.
The recalled product
- Product
- ProxiDiagnost N90 R.1.0
- 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 (19)
- REF number 706100 Serial number 10001015
- 10001019
- 10001020
- 10001021
- 10001022
- 10001023
- 10001026
- 10001027
- 10001028
- 10001030
- 10001033
- 10001036
- 10001037
- 10001038
- 10001039
- 10001040
- 10001042
- 10001051
- 20000067.
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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