Digital Angiography System Bransist safire Generator Model D150GC-40
Reported: March 9, 2022 Initiated: December 16, 2021 #Z-0654-2022
Product Description
Digital Angiography System Bransist safire Generator Model D150GC-40
Reason for Recall
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.
Details
- Recalling Firm
- Shimadzu Medical Systems
- Units Affected
- 18
- Distribution
- U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
Digital Angiography System Bransist safire Generator Model D150GC-40. Recalled by Shimadzu Medical Systems. Units affected: 18.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0654-2022.
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