Z-0488-2019Class II

Sedecal NOVA FA DR System. for diagnostic radiography

Name: Z-0488-2019 Sedecal NOVA FA DR System. for diagnostic radiography
Creator: Sedecal S.A.
Published: 2018-07-18
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2018-07-18 / Open, Classified / root cause: design

FDA source

Sedecal S.A. began a recall of Sedecal NOVA FA DR System. for diagnostic radiography on 2018-07-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0488-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-18
Posted: 2018-11-20
Recalling firm: Sedecal S.A.
Product: Sedecal NOVA FA DR System. for diagnostic radiography.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: design
FDA 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 in commerce: 145 units
Distribution: US and Canada
Product codes and lots: Serial Numbers 07360816 through 17291024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-11-28	2018-11-20

Product code MQB

K133782Class IINova Fa Dr SystemSedecal., Sa. / cleared 2014-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)