Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep
Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.
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 prolonged operation, which is a regulatory compliance issue and a potential safety risk, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 3 units of the DuraDiagnost Stationary X-ray System. The recall is due to a failure to comply with 21CFR 1020.31(j), which requires the system to emit a beep upon the termination of an exposure.
The defect occurs when the system has been powered on for over 12 hours. In this state, the system will no longer emit the termination signal. This lack of an audible cue could potentially affect the safety of the exposure process.
The affected units were distributed nationwide and in numerous countries, including Australia, Austria, Argentina, Canada, China, and others. Users of these systems should contact Philips Medical Systems for further instructions on how to address this compliance issue.
The recalled product
- Product
- Philips Healthcare DuraDiagnost X- Ray
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 3
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)
- DuraDiagnost Stationary X-ray System.
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.
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