Use cautionMedical device recall · FDA · Published October 14, 2021
SEDECAL MobileDiagnost wDR: Risk of Unintended Movement During Cleaning
SEDECAL recalls MobileDiagnost wDR models 712001-712007 due to potential unintended movement if excessive liquid is used during cleaning, which could cause short circuits.
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
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Contact the company
📍Recalling firmSEDECAL SAPELAYA, 9 POL., POL. IND. RIO DE JANEIRO · Algete, Spain
“SEDECAL MobileDiagnost wDR: Risk of Unintended Movement During Cleaning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61681-sedecal-mobilediagnost-wdr-risk-of-unintended-movement-during-cleaning. Based on FDA recall #Z-1083-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1083-2024%22&limit=1).
SEDECAL SA voluntarily recalled MobileDiagnost wDR devices on Oct. 14, 2021, according to the FDA. The recall addresses a hazard where excessive liquid during cleaning could cause a short circuit and unintended movement of the system.
How to tell if you have it
Brand: SEDECAL
Product: MobileDiagnost wDR
Model numbers: 712001, 712002, 712004, 712006, and 712007
Quantity: 851 devices
The hazard
If the cleaning or disinfecting process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
Context
GovInfoNow's records show SEDECAL SA has 6 other recalls on record since Aug. 12, 2022. Other recent recalls of similar products include SEDECAL SM-40HF-B-D-C Mobile X-ray System: Not Water-Resistant (June 10, 2025) and SEDECAL Battery Mobile X-ray Unit EASY MOVING Model 3.1: Anti-fall system interference risk (Jan. 22, 2024).
How to tell if you have this one
Check for model numbers 712001, 712002, 712004, 712006, or 712007 on your MobileDiagnost wDR. Each model has specific serial numbers listed in the recall notice.
Brand
SEDECAL
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Follow Cleaning Instructions
Use the device's manual to ensure proper cleaning procedures are followed to avoid excessive liquid or direct spraying.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution. There was government distribution but no military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2.4 years 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-1083-2024 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1083-2024 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.