Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1554-2015·Announced 2015-05-27

Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal

Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.

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: The recall is classified as FDA Class II. The hazard involves a failure to emit a safety signal (beep) after exposure, which is a compliance issue with potential for temporary or reversible consequences, fitting the Moderate category for minor labeling or functional errors without reported severe injury.

Plain-English summary

Philips Medical Systems, Inc. is recalling 54 units of the Philips Healthcare DigitalDiagnost System X-Ray. The affected systems are the Digital Diagnost Stationary X-ray System running Release 4.0.0, 4.0.1, or 4.0.2. These devices were distributed nationwide and in numerous countries worldwide, including Australia, Canada, China, Germany, India, Japan, and the United Kingdom.

The recall is due to a software defect where the system fails to emit a beep upon the termination of an X-ray exposure if the system has been powered on for more than 12 hours. This failure to provide the audible signal is a non-compliance with 21CFR 1020.31(j). The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: Philips Healthcare DigitalDiagnost System X-Ray
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — X-Ray Imaging
Hazard: software-defect
missing-signal
Affected units: 54

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 (3)

Digital Diagnost Stationary X-ray System Release 4.0.0
4.0.1
4.0.2

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems, Inc. 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 2 products in this recall →

Same manufacturer · Philips Medical Systems, Inc.

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