Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Digital Angiography System Bransist safire Generator Model D150GC-40 Recalled by Shimadzu Medical Systems Due to Due to the inadequate adjusting criteria in installation,...

Date: December 16, 2021
Company: Shimadzu Medical Systems
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shimadzu Medical Systems directly.

Affected Products

Digital Angiography System Bransist safire Generator Model D150GC-40

Quantity: 18

Why Was This 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.

Where Was This Sold?

This product was distributed to 15 states: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX, WA

Affected (15 states)Not affected

About Shimadzu Medical Systems

Shimadzu Medical Systems has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report