FDA Medical Device Recalls (openFDA)
Sedecal S.A.: Sedecal NOVA FA DR System. for diagnostic radiography.
- Recall number
- Z-0488-2019
- Recalling firm
- Sedecal S.A.
- Product
- Sedecal NOVA FA DR System. for diagnostic radiography.
- Status
- Open, Classified
- Initiated
- 2018-07-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- Initial communication from SEDECAL to all our distributors was performed on 07/18/2018 by email. The letter explained the problem and requested the consignee cease use of the unit if they observe an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement.
- Quantity
- 145 units
- Distribution
- US and Canada
- Lot, serial or model codes
- Serial Numbers 07360816 through 17291024
- 510(k) numbers
- ["K133782"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3002495042
- Firm city
- Algete
- Firm state
- not on file
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28