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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGFA N.V. DR 800 SYSTEM, X-RAY, TOMOGRAPHIC

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AGFA N.V. DR 800 SYSTEM, X-RAY, TOMOGRAPHIC Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  malfunction  
Event Description
A customer in germany reported to agfa, while using the dr 800 system, a problem with the tomosynthesis sequence. The customer reported the dr 800 tomosynthesis sequence started normally, but when the system reached the end position, the exposures did not stop. The system operator manually interrupted the sequence. The operator also reported the sequence would not archive. Investigation and corrective action planning is underway with the supplier and agfa. A supplemental report will be provided.
 
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Brand NameDR 800 SYSTEM, X-RAY, TOMOGRAPHIC
Type of DeviceDR 800
Manufacturer (Section D)
AGFA N.V.
septestraat 27
mortsel, B2640
BE B2640
Manufacturer (Section G)
AGFA N.V.
septestraat 27
mortsel, B2640
BE B2640
Manufacturer Contact
cassandra mcgowan
10 s academy street
greenville, SC 29601
8644211984
MDR Report Key9454142
MDR Text Key191310604
Report Number3001556265-2019-00013
Device Sequence Number1
Product Code IZF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K183275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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