Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2016 - (Recall #: Z-1599-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 1, 2016

Date Posted: May 11, 2016

Recall Number: Z-1599-2016

Event ID: 73668

Reason for Recall:

Reports of failure of the device's power supply.

Status: Terminated

Product Quantity: 2,062 devices

Code Information:

All serial numbers.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated