Z-0959-2019Class II

BRANSIST safire

Name: Z-0959-2019 BRANSIST safire
Creator: Shimadzu Medical Systems Usa Com
Published: 2019-01-14
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2019-01-14 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems Usa Com began a recall of BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or... on 2019-01-14. FDA classified it as Class II and gives the reason as "Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by...". 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-0959-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Posted: 2019-02-27
Terminated: 2024-06-07
Recalling firm: Shimadzu Medical Systems
Product: BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
Root cause tag: software
FDA root cause: Software design
Action: Shimadzu sent an Urgent Medical Device Correction Notice letter dated January 2, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
Quantity in commerce: 8 units
Distribution: US Nationwide Distribution in the states of IN, OH, IL, SC
Product codes and lots: Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-26

Product code IZI

K062360Class IIBransist SafireShimadzu Corp. / cleared 2006-10-05

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)