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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

SEDECAL SA: MobileDiagnost wDR Systems Recalled for Unintended Movement Risk

Agency Publication Date: February 14, 2024
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Summary

SEDECAL SA is recalling approximately 851 MobileDiagnost wDR mobile X-ray systems because cleaning or disinfecting the device with excessive liquid can cause a short circuit in the positioning control button. This defect can lead to the heavy medical equipment moving on its own in a slow, forward circular motion without operator input. This recall affects five specific model numbers (712001, 712002, 712004, 712006, and 712007) distributed nationwide across the United States. Owners should contact the manufacturer or their healthcare provider for further instructions regarding system maintenance and potential repairs.

Risk

A short circuit in the fine positioning button, caused by liquid ingress, can trigger unintended motorized movement of the system. This poses a risk of collision or entrapment for patients and staff if the device moves unexpectedly during a procedure or while being cleaned.

What You Should Do

  1. Identify if your facility has MobileDiagnost wDR systems with model numbers 712001, 712002, 712004, 712006, or 712007.
  2. For models 712006 and 712007, cross-reference your device serial numbers against the affected list, which includes specific units like SN20410556, SN21410184, and various SN2041, SN2141, and SNZY-prefixed codes.
  3. Review and strictly follow the cleaning and disinfection procedures described in the system manual; specifically, do not spray liquids directly on the system or use excessive amounts of cleaning solution.
  4. If you experience unintended movement or suspect a short circuit, stop using the positioning control features and contact SEDECAL SA or your authorized distributor immediately.
  5. Contact your healthcare provider or SEDECAL SA for further technical instructions, potential system inspections, and information regarding a remedy.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction through updated cleaning instructions and contact with manufacturer.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MobileDiagnost wDR (Model 712001)
Model / REF:
712001
UPC Codes:
00884838028586
Lot Numbers:
All serial numbers
Product: MobileDiagnost wDR (Model 712002)
Model / REF:
712002
UPC Codes:
00884838082373
Lot Numbers:
All serial numbers
Product: MobileDiagnost wDR (Model 712004)
Model / REF:
712004
UPC Codes:
08436046002173
Lot Numbers:
All serial numbers
Product: MobileDiagnost wDR (Model 712006)
Model / REF:
712006
UPC Codes:
00884838091504
Lot Numbers:
SN20410556
SN21410184
Product: MobileDiagnost wDR (Model 712007)
Model / REF:
712007
UPC Codes:
08436046002357
Lot Numbers (162):
26
27
19410038
19410044
19410046
21410261
21410266
21410280
21410288
21410290
21410291
21410293
21410294
21410339
21410340
21410341
21410342
21410345
22410022
22410023
SN0410157
SN1410049
SN19410034
SN19410035
SN19410036
SN19410037
SN19410071
SN19410092
SN19410093
SN19410094
SN19410097
SN19410098
SN19410099
SN19410100
SN19410101
SN19410102
SN19410115
SN19410116
SN19410123
SN19410127
SN19410129
SN19410135
SN19410136
SN19410137
SN20410029
SN20410030
SN20410032
SN20410033
SN20410034
SN20410044

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93651
Status: Active
Manufacturer: SEDECAL SA
Sold By: Government distribution; Direct medical device distributors
Manufactured In: Spain
Units Affected: 851 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.