FDA Device recall Z-3111-2017
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube sup…
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube sup… by Toshiba American Medical Systems, citing 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 erro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3111-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-23 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial No. W8B1572022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3111-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.