Portable X-ray system may move unexpectedly if improperly cleaned
The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. The hazard involves potential unwanted equipment movement due to liquid damage during improper cleaning, representing a documented risk of harm without reported harm, meeting the rubric criterion for High severity.
Plain-English summary
The FDA has issued a recall for the MobileDiagnost wDR portable diagnostic X-ray system, models 712001, 712002, 712004, 712006, and 712007. The recall was issued because excessive liquid used during cleaning or disinfection can cause a short circuit in the fine positioning control button. This failure causes the system to move on its own in a slow forward circular motion, posing a risk to patients and operators.
A total of 851 devices are affected by this recall. The systems were distributed nationwide in the United States.
Users of the MobileDiagnost wDR system should follow the manufacturer's cleaning and disinfection instructions in the product manual carefully. Contact the manufacturer or distributor with questions about proper maintenance procedures.
The recalled product
- Product
- MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
- Manufacturer
- SEDECAL SA
- Affected units
- 851
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model 712001 - UDI-DI 00884838028586
- all serial numbers
- Model 712002 - UDI-DI 00884838082373
- Model 712004 - UDI-DI 08436046002173
- Model 712006 - UDI-DI 00884838091504
- serial numbers: SN20410556 and SN21410184
- Model 712007 - UDI-DI)08436046002357
- serial numbers: 26
- 27
- 19410038
- 19410044
- 19410046
- 21410261
- 21410266
- 21410280
- 21410288
- 21410290
- 21410291
- 21410293
- 21410294
Distribution
Distributed nationwide across the United States.
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