Z-2060-2018Class II

Sonialvision Safire II, Model #: DAR-8000f

Name: Z-2060-2018 Sonialvision Safire II, Model #: DAR-8000f
Creator: Shimadzu Medical Systems
Published: 2018-01-12
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2018-01-12 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems began a recall of Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with... on 2018-01-12. FDA classified it as Class II and gives the reason as "When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray...". 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-2060-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-06-14
Terminated: 2022-02-24
Recalling firm: Shimadzu Medical Systems
Product: Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
Root cause tag: software
FDA root cause: Software design
Action: Shimadf0u sent an Urgent Voluntary Medical Device Recall Notice letter dated January 2018. The letter identified the affected product, problem and actions to be taken. For questions contact Shimadzu representative or contact Shimadzu National Technical Support at 800-228-1429.
Quantity in commerce: 17
Distribution: US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Product codes and lots: Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2060-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2060-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14

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)