Z-0488-2019 Class II Ongoing
FDA device recall Z-0488-2019 was initiated by Sedecal S.A. on Jul 18, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 145 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Jul 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145 units
Product Description
Sedecal NOVA FA DR System. for diagnostic radiography.
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.
Distribution Pattern
US and Canada
Code Information
Serial Numbers 07360816 through 17291024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0488-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026