Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1588-2023·Announced 2023-05-24

Philips diagnostic imaging systems recalled for missing FDA certification labels

Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

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 medical device recall with a labeling compliance issue (missing certification label). No reported illnesses, injuries, or direct patient safety risks are described; the issue is regulatory non-compliance rather than an inherent hazard to device function.

Plain-English summary

Philips North America is recalling the CombiDiagnost R90 R.1.0 and related diagnostic systems that are missing a certification label required by the Food and Drug Administration (FDA). A total of 25 systems have been distributed nationwide in the United States.

These missing certification labels represent a compliance issue with FDA regulations governing medical device labeling. The labels are required by FDA for proper regulatory oversight and tracking of medical devices.

Owners and operators of these systems should verify whether their devices are affected by checking the product model and serial information. Facility managers should contact Philips North America for instructions on obtaining the required certification label and addressing this compliance issue.

The recalled product

Product: CombiDiagnost R90 R.1.0
Manufacturer: Philips North America
Category: Medical Device — Diagnostic Imaging
Hazard: missing-certification-label
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 (1)

REF number 709030 Serial number 10001076

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.

See all 3 products in this recall →

Same manufacturer · Philips North America

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Same hazard · missing certification label