Recall Z-1569-2014— Shimadzu Medical Systems

Name: FDA recall Z-1569-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2014-04-03, terminated 2015-06-25. It names one FDA 510(k) clearance: K052500. Product: Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.. Reason: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2015-06-25
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K052500 — DAR-8000FShimadzu Medical Systems·cleared 2005-10-17

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

Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

Reason for recall

Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

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