Sonialvision Safire II — Class II medical device recall Z-2060-2018
Terminated recall by Shimadzu Medical Systems, reported 2018-06-20, distributed nationwide. When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pu
| Recall number | Z-2060-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 17 |
| Serial numbers | 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003, 3M72BFB35005, 3M72BFB46002, 3M72BFC2A001, 3M72BFC2C001, 3M72BFC33001, 3M72BFC34001, 3M72BFC37002, 3M72BFC42001 |
| Model numbers | DAR-8000F |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2060-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.