Recall Z-0655-2022— Shimadzu Medical Systems
Class II · Ongoing
Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2021-12-16. It names one FDA 510(k) clearance: K123508. Product: Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40. Reason: 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..
- Recalling firm
- Shimadzu Medical Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-16
- Firm location
- Torrance, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Digital Angiography System Shimadzu Trinias 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.