Sedecal NOVA FA DR System Recalled for Potential Cable Failure
Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (cable breakage) that could cause the equipment to fall, posing a significant risk of injury to patients and users, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Sedecal S.A. is recalling 145 units of the NOVA FA DR System used for diagnostic radiography. The recall affects serial numbers 07360816 through 17291024, which were distributed in the United States and Canada.
The recall is due to a safety problem with installation and maintenance that could lead to the breakage of the two steel cables supporting the equipment to its roof anchor. If these cables break, the equipment may fall and cause harm to the patient, user, or third parties.
Consumers and healthcare facilities should contact Sedecal S.A. for instructions on how to address this safety issue.
The recalled product
- Product
- Sedecal NOVA FA DR System. for diagnostic radiography.
- Manufacturer
- Sedecal S.A.
- 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)
- Serial Numbers 07360816 through 17291024
Distribution
Distribution scope not specified by the agency.
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