Sedecal Mobile X-ray System Recalled for Software Defect
Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.
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 (x-ray system) where injury has not yet been reported, fitting the High severity criteria for potential harm without confirmed incidents.
Plain-English summary
Sedecal USA, Inc. is recalling 145 Sedecal SA Mobile Diagnost w DR x-ray systems in the United States. The recall is due to a software defect in the Eleva User Interface.
The defect may cause the system to sporadically apply default x-ray exposure parameters for an adult (patient type: Normal) even when the patient type "Newborn" is selected and displayed. This issue affects systems distributed across 30 states, including Texas, Ohio, New York, and California.
Healthcare providers should contact Sedecal USA for instructions on how to resolve the software defect. The recall number is Z-1691-2016.
The recalled product
- Product
- Sedecal SA Mobile Diagnost w DR x-ray system
- Manufacturer
- Sedecal USA, Inc.
- Affected units
- 145
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 (1)
- System Code 712001
Distribution
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