Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal
Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a safety signal (beep) fails, creating a risk of harm during use, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 62 units of the DigitalDiagnost Release 4.0.3 and Release 4.1/4.1.1 X-ray systems. The recall excludes systems that have already been updated with Service Pack 1 (SP1). These devices are intended for use by qualified doctors or technicians to generate radiographic images of human anatomy.
The recall is due to a defect in the Microsoft Windows 7 operating system used by the devices. The system is designed to emit a beep when an X-ray exposure terminates. However, if the system has been powered on for more than 12 hours, it will no longer emit this signal. This failure to provide an audible cue could impact the safety of the imaging procedure.
The affected units were distributed nationwide in the United States, specifically to Arizona, Minnesota, Washington, Wyoming, and Ohio. The devices were also distributed internationally to Canada. Users of these systems should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 62
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)
- DigitalDiagnost
Distribution
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