Model Number 1.006.2581 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to the manufacturer on 16-december-2016 and is undergoing evaluation.Upon completion of the evaluation, a follow-up report will be submitted.
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Event Description
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The customer reported that the device tubehead became dislodged from the articulated arm and was hanging by the wires during a patient scan.The tubehead did not make contact with the patient.No injuries have been reported.
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Manufacturer Narrative
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(b)(6).The unit was returned to the manufacturer on 16-december-2016 and the evaluation was completed on 22-march-2017.Visual inspection of the returned unit confirmed the reported symptom that the tube head had become dislodged from the articulated arm at the pivot joint assembly and was hanging by the electrical wires through the articulated arm.Visual inspection of the pivot joint assembly revealed material deformation on the inside of the pivot joint casting and material transfer on the pivot joint shaft.Based on the investigation and dhr review, the root cause of the failure was determined to be a compromised press fixture that resulted in the pivot shaft being slightly misaligned with the pivot casting during the pivot joint press process.No remedial action has been deemed necessary for the low risk of substantial harm to the public health this failure mode represents.This concludes our investigation.
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Search Alerts/Recalls
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