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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION SMART CR; COMPUTED RADIOGRAPHY SYSTEM

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FUJIFILM CORPORATION SMART CR; COMPUTED RADIOGRAPHY SYSTEM Back to Search Results
Model Number CR-IR346RU
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2016
Event Type  malfunction  
Manufacturer Narrative
This report is being made out of an abundance of caution.Dealer service engineer visited site and evaluated device to determine cause of event.Power supply was replaced and the device was returned to use.The site information is: (b)(6).A cr reader unit is used for reading x-ray images that have been exposed on a cr image plate.The smartcr is also known as an xg-1 or a cr-ir 346.There is no indication the system was being used to read image plates at the time of the event.No patients were reported as being involved in the event and no reports of injury were alleged or provided by the reporter.Fujifilm submitted the correction report identified in recall on march 22, 2016.This addresses a corrective action that will replace the power supply in all smart cr systems.Notification to users was made.
 
Event Description
On friday (b)(6) 2016 (b)(4) called to report that the xg-1 (smartcr) at their customer site, (b)(6) allegedly experienced a smoking smart cr ( serial number:(b)(4)) incident on (b)(6).At the point that this reported smoking incident occurred the site had not had car-102 performed.The dealer has been on site and replaced the power supply.There was no indication the system was being used to read image plates at the time of the event.No patients were reported as being involved in the event and no reports of injury were alleged or provided by the reporter.
 
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Brand Name
SMART CR
Type of Device
COMPUTED RADIOGRAPHY SYSTEM
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA  258-8538
Manufacturer (Section G)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA   258-8538
Manufacturer Contact
peter altman
419 west ave
stamford, CT 06902
2036023576
MDR Report Key5708734
MDR Text Key46890204
Report Number2443168-2016-00006
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCR-IR346RU
Device Catalogue NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/03/2016
Initial Date FDA Received06/09/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction Number2443168-16/3/22-001-C
Patient Sequence Number1
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