Z-1599-2016Class II

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

Name: Z-1599-2016 Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2016-04-01
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2016-04-01 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU on 2016-04-01. FDA classified it as Class II and gives the reason as "Reports of failure of the device's power supply". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1599-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Posted: 2016-05-03
Terminated: 2018-07-11
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Product code: IXW Processor, Radiographic-Film, Automatic
Reason for recall: Reports of failure of the device's power supply.
Root cause tag: design
FDA root cause: Device Design
Action: Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.
Quantity in commerce: 2,062 devices
Distribution: Nationwide Distribution.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1599-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03

Product code IXW

K944046Class IIFuji Computed Radiography SystemsFujifilm Medical System U.S.A., Inc. / cleared 1995-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)