Recall Z-1599-2016— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-1599-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-01

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2016-04-01, terminated 2018-07-11. It names one FDA 510(k) clearance: K944046. Product: Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU. Reason: Reports of failure of the device's power supply..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Terminated: 2018-07-11
Firm location: Stamford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K944046 — FUJI COMPUTED RADIOGRAPHY SYSTEMSFujifilm Medical System U.S.A., Inc.·cleared 1995-05-11

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

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Reason for recall

Reports of failure of the device's power supply.

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