CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Sonialvision Safire II recalled by Shimadzu Medical Systems
Shimadzu Medical Systems is recalling Sonialvision Safire II, distributed nationwide in the US. The recall was initiated on 12 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2060-2018
- FDA event ID
- 80067
- Recalling firm
- Shimadzu Medical Systems, Torrance, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 14 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 14 Jun 2018 | Classified by FDA | +153 days |
| 20 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Nationwide ArizonaCaliforniaFloridaIllinoisLouisianaMichiganNew JerseySouth CarolinaTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002
Where was it sold?
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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