Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
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 (un-commanded movement of medical equipment) that could cause injury, with no injuries reported in the source text. The FDA classified this as Class II; the hazard is clear but impacts are theoretical rather than confirmed.
Plain-English summary
Sedecal SA is recalling 155 Soltus Battery Mobile X-Ray Systems (models Soltus 450 and Soltus 500) due to a potential for un-commanded movement of the mobile x-ray unit. These diagnostic x-ray systems have been distributed to healthcare facilities across multiple U.S. states including Kentucky, Wisconsin, Florida, Delaware, West Virginia, California, Missouri, New York, North Carolina, and many others.
The un-commanded movement poses a safety risk to patients and healthcare workers who may be in proximity to the equipment. Healthcare facilities in possession of these systems should immediately discontinue their use.
Affected units can be identified by their specific serial numbers and UDI codes provided by Sedecal SA. Facilities should verify whether their systems match the recalled serial numbers and UDI codes listed in the FDA recall notice and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
- Manufacturer
- SEDECAL SA
- Hazard
- Affected units
- 155
Distribution
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