Toshiba Medical Radrex-i Digital Radiography X-ray System Recalled for Software Error
Toshiba American Medical Systems is recalling 140 Radrex-i digital radiography systems because a software error causes image loss and requires a system reboot.
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 explicitly states no injuries or illnesses were reported, and the hazard is limited to software malfunction and data loss rather than physical harm.
Plain-English summary
Toshiba American Medical Systems is recalling 140 units of the Toshiba Medical Radrex-i Digital Radiography X-ray system. The recall is due to a software issue where an error message, "System Error (2063)," is displayed when an operator makes an exposure on the wireless x-ray detector and sends the image data to the system. This error requires a reboot of the system and results in the loss of the acquired image.
The affected systems are intended for use in conjunction with ceiling suspended tube supports, high voltage generators, and bucky stands or tables incorporating fixed or detachable flat panel detectors for radiography of the head, chest, abdomen, spine, neck, and limbs. The recall covers units distributed nationwide in the United States. The specific serial number identified in the recall notice is W8B1572022.
No injuries or illnesses have been reported in connection with this recall. The hazard is limited to the loss of image data and the operational interruption caused by the required system reboot. Healthcare facilities should contact Toshiba American Medical Systems for further instructions on how to resolve the software issue.
The recalled product
- Product
- Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction 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…
- Manufacturer
- Toshiba American Medical Systems
- Hazard
- Affected units
- 140
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 No. W8B1572022
Distribution
Distributed nationwide across the United States.
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