FDA Device recall Z-2045-2023
wDR 2.2 Mobile Digital Diagnostic X-Ray System
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of wDR 2.2 Mobile Digital Diagnostic X-Ray System by Sedecal, citing there is a software login in issue that may prevent the user from logging in.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2045-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-23 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sedecal |
| Distribution | PR |
Product
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Reason
There is a software login in issue that may prevent the user from logging in.
Identifiers
| code_info | Model MobileDiagnost wDR: 1) Model Number 712007, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 2) Model Number 7120…Model MobileDiagnost wDR: 1) Model Number 712007, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 2) Model Number 712006, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 3) Model Number 712004, Software version 2.1 with Windows 10 Upgrade 4) Model Number 712002, Software version 2.1 with Windows 10 Upgrade |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2023%22
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