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U.S. Department of Health and Human Services

Class 2 Device Recall Smart CR Digital Computed Radiography System

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 Class 2 Device Recall Smart CR Digital Computed Radiography Systemsee related information
Date Initiated by FirmApril 01, 2016
Create DateMay 03, 2016
Recall Status1 Terminated 3 on July 11, 2018
Recall NumberZ-1599-2016
Recall Event ID 73668
510(K)NumberK944046 
Product Classification Processor, radiographic-film, automatic - Product Code IXW
ProductSmart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
For Additional Information Contact
888-385-4633 Ext. 2
Manufacturer Reason
for Recall		Reports of failure of the device's power supply.
FDA Determined
Cause 2		Device Design
ActionFujifilm 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 Commerce2,062 devices
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IXW
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