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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 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
This report is being made out of an abundance of caution. Service engineer visited site and evaluated device to determine cause of event. He replaced power supply, checked device for proper operation after repair and the device was returned to use. Power supply was returned to fujifilm in (b)(4) for analysis by manufacturer. 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 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
A service call was placed for the smart cr unit (s/n (b)(4)) at about 2am cst on (b)(6) 2016. Customer alleges smoke coming from the unit. Hospital staff unplugged the unit and awaited service. Service engineer arrived on-site later that day and determined the power supply to be the issue. A new power supply was ordered (b)(4) and replaced the following day, (b)(6) 2016. The unit was turned over to the hospital in good working order. 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 NameSMART CR
Type of DeviceCOMPUTED 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 Key5696444
MDR Text Key46468566
Report Number2443168-2016-00005
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 user facility
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 06/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2016
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2443168-16/3/22-001-C

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