Sedecal NOVA FA DR System. for diagnostic radiography.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers 07360816 through 17291024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sedecal S.A.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Sedecal NOVA FA DR System. for diagnostic radiography.
Product Codes/Lot Numbers:
Serial Numbers 07360816 through 17291024
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0488-2019
Related Recalls
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.