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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION JB-70 INTRAORAL DENTAL X-RAY SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER

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MIDMARK CORPORATION JB-70 INTRAORAL DENTAL X-RAY SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
Model Number JB-70
Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 07/20/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, a servicing technician reported that a jb-70 intraoral dental x-ray system (serial no.(b)(4)) unexpectedly generated an exposure tone when it was powered on.The exposure tone is an audible signal that indicates that an x-ray image has been taken.There was no report of injury or patient involvement.The unit has since been replaced with a newer model.
 
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Brand Name
JB-70 INTRAORAL DENTAL X-RAY SYSTEM
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER
Manufacturer (Section D)
MIDMARK CORPORATION
675 heathrow dr.
lincolnshire IL 60069
Manufacturer Contact
adam foresman
675 heathrow drive
lincolnshire, IL 60069
8474159739
MDR Report Key5010852
MDR Text Key24781583
Report Number1423380-2015-00020
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Service Personnel
Remedial Action Replace
Type of Report Followup
Report Date 07/20/2015
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 Service Personnel
Device Model NumberJB-70
Device Catalogue NumberI7016-PG
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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