Recall Z-1040-2019— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-1040-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-15

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2019-01-15, terminated 2020-10-08. It names one FDA 510(k) clearance: K080701. Product: Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>. Reason: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-15
Terminated: 2020-10-08
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 Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

Reason for recall

FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

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