Sedecal NOVA FA DR System. for diagnostic radiography recall
Sedecal NOVA FA DR System. for diagnostic radiography.
Why was Sedecal NOVA FA DR System. for diagnostic radiography recalled?
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers 07360816 through 17291024
- Product
- Sedecal NOVA FA DR System. for diagnostic radiography.
- Recalling firm
- Sedecal S.A.
- Quantity
- 145 units
- Distribution
- US and Canada
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)