Lower riskMedical device recall · FDA · Published May 23, 2023
SEDECAL wDR 2.2 Mobile X-Ray System: Software Login Issue Prevents User Access
SEDECAL recalls wDR 2.2 Mobile Digital Diagnostic X-Ray Systems with specific software versions that may prevent user login. Affected models include 712007, 712006, 712004, and 712002 with listed software versions. No remedy is provided in the recall notice.
There is a software login in issue that may prevent the user from logging in.
Take action
Contact the company
📍Recalling firmSEDECAL SAPELAYA, 9 POL., POL. IND. RIO DE JANEIRO · Algete, Spain
✎ GovInfoNow plain-language explainer
SEDECAL is recalling wDR 2.2 Mobile Digital Diagnostic X-Ray Systems with specific software versions that may prevent users from logging in. This issue could disrupt medical operations but does not pose a direct safety risk to patients or users. Read more at govinfonow.com/recall/58107-sedecal-wdr-2-2-mobile-x-ray-system-software-login.
“SEDECAL wDR 2.2 Mobile X-Ray System: Software Login Issue Prevents User Access.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58107-sedecal-wdr-2-2-mobile-x-ray-system-software-login. Based on FDA recall #Z-2045-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2023%22&limit=1).
SEDECAL SA recalled its wDR 2.2 Mobile Digital Diagnostic X-Ray System due to a software login issue that may prevent users from logging in, according to the FDA on May 23, 2023.
How to tell if you have it
Brand: SEDECAL
Product: wDR 2.2 Mobile Digital Diagnostic X-Ray System
Model Number 712007 with Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
Model Number 712006 with Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
Model Number 712004 with Software version 2.1 with Windows 10 Upgrade
Model Number 712002 with Software version 2.1 with Windows 10 Upgrade
The hazard
The recall involves a software login issue that may prevent the user from logging in, according to the FDA.
Context
GovInfoNow's records show SEDECAL SA has issued six other recalls since October 14, 2021. Other recent recalls of similar products include GE Medical Systems Centricity Universal Viewer Software Cybersecurity Recall (January 30, 2026), Siemens SOMATOM X.ceed Software Applications Recall (December 19, 2025), and Philips Azurion X-Ray System Recall (June 17, 2026).
How to tell if you have this one
Check your wDR 2.2 Mobile X-Ray System model number (712007, 712006, 712004, or 712002) and software version (2.2.0 to 2.2.3 or 2.1 with Windows 10 Upgrade).
Brand
SEDECAL
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your system's software version against the listed versions (2.2.0 to 2.2.3 or 2.1 with Windows 10 Upgrade) to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2045-2023 (May 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2045-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.