Z-2060-2018 Class II Terminated
FDA device recall Z-2060-2018 was initiated by Shimadzu Medical Systems on January 12, 2018 and is designated Class II. 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… The recall status is terminated (terminated February 24, 2022). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- January 12, 2018
- Termination Date
- February 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
Product Description
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.
Distribution Pattern
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Code Information
Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002