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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZMICRO, INC CLARITY SYSTEM, IMAGE PROCESSING

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ZMICRO, INC CLARITY SYSTEM, IMAGE PROCESSING Back to Search Results
Model Number ZMED-2XYAC-019
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2019
Event Type  malfunction  
Manufacturer Narrative
This is a fictitious submission for purposes of escalation to a production account.
 
Event Description
This is a test submission for migration from a test account to a production account. No actual event occurred.
 
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Brand NameCLARITY
Type of DeviceSYSTEM, IMAGE PROCESSING
Manufacturer (Section D)
ZMICRO, INC
9820 summers ridge road
san diego CA 92121 3083
Manufacturer (Section G)
ZMICRO
9820 summers ridge road
san diego CA 92121 3083
Manufacturer Contact
kari niebell
9820 summers ridge road
san diego, CA 92121-3083
8588317029
MDR Report Key8351251
MDR Text Key136855488
Report Number3008142630-2019-70001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130929
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberZMED-2XYAC-019
Device Catalogue Number0240-260-000
Device Lot NumberM11370.51
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age2 MO
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1
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