Shimadzu Medical Systems Digital Angiography System Bransist safire Generator Model D150GC-40 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Recommended Action

Per FDA guidance

On 12/13/2021, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to distributors who hand-delivered to customers informing them that there is a potential issue with the adjustment procedure for the calibration of the x-ray generators for the Digital Angiography Systems and occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. Customers are instructed to: -Check their systems for the affected generators. -Contact their distributor to schedule a system update and calibration. -If customers feel there are any issues with their system, they are asked to discontinue use of the system and contact their local service providers. The Recalling Firm has identified that affected units and have informed the authorized service representatives. The authorized servicers should be contacting customers to schedule time to implement the corrective action (update and calibrate). Customers can contact the Recalling Firm's National Technical Support at: Toll Free: (844)487-2767 available 8:00 a.m. to 5:00 p.m. Monday thru Friday On 01/07/2022, an updated "Urgent: Voluntary Medical Device Recall Letter" will be communicated to customer to provide additional instruction on how to identify an issue with their system which would indicated to cease using until the system has been corrected.

Distribution

As reported by FDA

CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX, WA