Toshiba Medical Radrex — Class II medical device recall Z-3111-2017
Terminated recall by Toshiba American Medical Systems, reported 2017-09-20, distributed nationwide. It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector an
| Recall number | Z-3111-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Toshiba American Medical Systems, Tustin, CA, United States |
| Recall initiated | 2017-03-23 |
| Classified | 2017-09-11 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2020-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 140 |
| Serial numbers | W8B1572022 |
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 radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.
Reason for recall
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3111-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.