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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELERAD MEDICAL SYSTEMS INTELEPACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

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INTELERAD MEDICAL SYSTEMS INTELEPACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number INTELEPACS INTELEVIEWER 4-10-1 AND UP
Device Problems Output Problem (3005); No Apparent Adverse Event (3189); Program or Algorithm Execution Failure (4036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2020
Event Type  malfunction  
Event Description
A hazard may arise when non-dicom compliant jpeg-2000-compressed images are received by the (b)(6) component with dicom bit depth (bits stored tag) that does not match the bit depth in the pixel data codestream. These images are decompressed with a loss of precision in the image data which can lead to failing image registration.
 
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Brand NameINTELEPACS
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
INTELERAD MEDICAL SYSTEMS
800, boul. de maisonneuve e.
12th floor
montreal, quebec H2L 4 L8
CA H2L 4L8
Manufacturer (Section G)
INTELERAD MEDICAL SYSTEMS
800, boul. de maisonneuve e.
12th floor
montreal, quebec H2L 4 L8
CA H2L 4L8
Manufacturer Contact
luce caron
800, boul. de maisonneuve e.
12th floor
montreal, quebec H2L 4-L8
CA   H2L 4L8
MDR Report Key10148184
MDR Text Key200853210
Report Number9615916-2020-00003
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K150707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINTELEPACS INTELEVIEWER 4-10-1 AND UP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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