Medical X-Ray System Recall Due to Parts Falling Off
Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.
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: FDA Class II recall for a medical device with a concrete risk of harm: parts have fallen off a diagnostic x-ray system. No injuries or hospitalizations have been reported, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sedecal SA is recalling the Sedecal X Optima URS digital mobile diagnostic x-ray system. Parts of the equipment have fallen off, creating a safety risk to patients and users.
The Sedecal X Optima URS is a stationary x-ray unit with a universal swivel arm designed to take diagnostic images of patients in various positions. The recall affects 845 units distributed to healthcare facilities in Alabama, Florida, and North Carolina, identified by UDI-DI 08436046002500.
If you use or maintain one of these systems, contact SEDECAL SA immediately for instructions to remediate the defect. Do not use the equipment until the defect has been corrected and verified.
The recalled product
- Product
- Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
- Manufacturer
- SEDECAL SA
- Affected units
- 845
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 (2)
- All serial numbers
- UDI-DI 08436046002500.
Distribution
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