Z-1569-2014Class II

Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for...

Name: Z-1569-2014 Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for...
Creator: Shimadzu Medical Systems
Published: 2014-04-03
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2014-04-03 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems began a recall of Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices on 2014-04-03. FDA classified it as Class II and gives the reason as "Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1569-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2014-05-08
Terminated: 2015-06-25
Recalling firm: Shimadzu Medical Systems
Product: Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
Root cause tag: software
FDA root cause: Software design
Action: A Service Bulletin and a customer notification letter were sent on 4/3/2014 for all the customers who purchased the Shimadzu Digital X-Ray System (Catalog No. DAR-8000f). The notification informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
Quantity in commerce: 685 units total (14 units in US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Product codes and lots: Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1569-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-08

Product code IZI

K052500Class IIDar-8000FShimadzu Medical Systems / cleared 2005-10-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)