Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure
Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.
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, but the source text describes a functional software error (image transmission failure) with no reported injuries, illnesses, or physical hazards, fitting the criteria for a moderate severity issue.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 28 units of the DRAD-3000E FPD Wireless System. This medical device is intended for use with ceiling-suspended tube supports and flat panel detectors for radiography of the head, chest, abdomen, spine, neck, and limbs.
The recall was initiated because users reported that when performing radiography, a message window appeared on the monitor stating that imaging transmission was not completed and no radiographic image was produced. Users who selected the "OK" button to re-acquire the image data encountered the same error repeatedly. The issue was resolved only when the user selected "Cancel" to terminate the re-acquisition process.
The affected units were distributed nationwide to Pennsylvania, Utah, Florida, New York, Louisiana, West Virginia, New Jersey, Ohio, Wisconsin, and Texas. The specific serial number for the affected unit is USB1522023. Users should contact Toshiba American Medical Systems Inc for further instructions on how to address this defect.
The recalled product
- Product
- Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the…
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 28
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)
- Serial number : USB1522023
Distribution
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