Shimadzu Medical Systems: Medical Device Recall in 2014 - (Recall #: Z-1569-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 3, 2014

Date Posted: May 14, 2014

Recall Number: Z-1569-2014

Event ID: 67927

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.

Status: Terminated

Product Quantity: 685 units total (14 units in US)

Code Information:

Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated