Recall Z-0655-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
| Date | Dec 16, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | 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 t |
| Quantity | 28 systems |
| Distribution | U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |