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U.S. Department of Health and Human Services


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Model Number 424007
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: guerbet technical support received a call from a hospital biomed stating that while a patient was on the table, their hvdis urology system, stopped producing x-rays. Although the biomed rebooted the imagining computer, they were unable to regain x-ray imaging. There was no harm to the patient, which was moved to another system to complete the procedure. Guerbet's technical support advised the biomed that the system may need to be reset by rebooting both the imaging computer as well as the generator. After performing the reset, xray ability was regained, and the system functioned normally. The event logs from both the imaging computer and the generator were downloaded for review by the manufacturers. Based on this review varex, the imaging system manufacturer, concluded that the operator removed his foot from the exposure foot pedal before the acquisition sequence was finished. This condition caused the generator to be out of synchronization with the imaging computer. When this occurred, the generator stopped producing pulses and sent an error code 57 to the imaging computer. Although it rarely occurs, this situation, in which the generator and computer loose communication when the user releases the `expose' pedal too soon is a software anomaly known by varex who issued technical advisory #227, which was explained to users. Varex will resolve this issue in an upcoming varex software enhancement version (b)(4), per the advisory notice. Root / probable cause code: equipment/instrument - software. Root / probable cause summary: refer to investigation summary : this is a known issue; the operator letting his/her foot off the pedal too soon, while being an operator error, can cause a situation where the system gets locked. That this happens is a software anomaly known by varex who issued a technical advisory #227 which was sent to service and applications personnel and explained to users. The ultimate fix will be in the next varex software enhancement, version (b)(4) no further investigation needed at this time. Qa will continue to monitor and trend for similar issues. No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action. Disposition summary: unit remained in service.
Event Description
Initial information was received on (b)(6) 2020, as reporter states that there was no patient on the table at the time of the first message on the system, which displayed that the x-ray tube is misalligned, but moved the imaging chain to rectify the interlock. They then perfomed a cas without issue. Reporter states that on the 2nd case, the system stopped makign x-ray. They cycled the nexus only, but did not get x-ray back. At this point, they moved the patient to another room. Reporter states that there are no messages on the table or the generator menu bar. The detector status is green. Reporter was told to cycle power on the spellman, but this did not help. The reporter then cycled power on the nexus and spellman, and this action rectified the issue.
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Manufacturer (Section D)
2111 e galbraith road
cincinnati, oh
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, oh 
MDR Report Key9961992
MDR Text Key196134118
Report Number1518293-2020-00007
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Remedial Action Notification
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number424007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage