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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIMADZU MEDICAL SYSTEMS RADSPEED PRO SYSTEM, X-RAY, STATIONARY

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SHIMADZU MEDICAL SYSTEMS RADSPEED PRO SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number RADSPEED PRO
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2019
Event Type  malfunction  
Event Description
This occurred on a general rad room. Digital pt images were lost due to software corruption. New software was loaded, wasn't realized till after the site tried to take pt images that the networking wasn't working. Windows software was updated which corrupted the medical x-ray images causing them to be unrecoverable.
 
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Brand NameRADSPEED PRO
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
SHIMADZU MEDICAL SYSTEMS
MDR Report Key9213722
MDR Text Key163114553
Report NumberMW5090482
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2020
Device Model NumberRADSPEED PRO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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