Sedecal MobileDiagnost wDR X-ray systems recalled for unexpected movement
Sedecal S.A. is recalling 283 MobileDiagnost wDR motorized portable diagnostic X-ray systems due to reports of unexpected movement.
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: The recall involves a risk-of-harm product (unexpected movement of a motorized medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sedecal S.A. is recalling 283 MobileDiagnost wDR motorized portable diagnostic X-ray systems. The recall was initiated due to reports of unexpected movement of the devices.
The affected units were distributed nationwide across 38 states and the District of Columbia. The specific serial numbers for the recalled units are listed in the official recall documentation.
Consumers and healthcare facilities should stop using the affected systems and contact Sedecal S.A. for instructions on how to proceed with the recall.
The recalled product
- Product
- MobileDiagnost wDR motorized portable diagnostic X-ray systems.
- Manufacturer
- Sedecal S.A.
- Hazard
- Affected units
- 283
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)
- Serial Numbers: 12000166
- 13000046
- 13000047
- 13000048
- 13000049
- 13000053
- 13000054
- 13000055
- 13000056
- 13000057
- 13000058
- 13000060
- 13000064
- 13000070
- 13000071
- 13000075
- 13000077
- 13000078
- 13000079
- 13000085
Distribution
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