RecallRadar

FDA Device recall Z-1599-2016

Smart CR Digital Computed Radiography System

On 2016-05-11 the FDA classified a Class II recall of Smart CR Digital Computed Radiography System by Fujifilm Medical Systems U, citing reports of failure of the device's power supply.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1599-2016
ClassificationClass II
Statusterminated
Initiated2016-04-01
Published2016-05-11
Last updated2026-09-13 11:54 UTC
CompanyFujifilm Medical Systems U
DistributionUS

Product

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

Reason

Reports of failure of the device's power supply.

Identifiers

code_infoAll serial numbers.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1599-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.