Recall Z-2441-2019— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-2441-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2019-07-19, terminated 2020-08-28. It names one FDA 510(k) clearance: K080701. Product: Fujifilm FDR Go Plus mobile X-ray system. Reason: The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD).

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Terminated: 2020-08-28
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K080701 — SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONShimadzu Corp.·cleared 2008-05-14

K-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

Fujifilm FDR Go Plus mobile X-ray system

Reason for recall

The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)

Data sourced from openFDA. This site is unofficial and independent of the FDA.