Results of manufacturer's final investigation (final report): the manufacturer's investigation found that the bug poses a risk for mistreatment in lgp 10.2, however they are not aware of any actual clinical mistreatments as a result of this issue.The risk was classified as consequence 4 (catastrophic) with probability at most 3 (remote).The manufacturer recommended that the problem is fixed in a new release that shall replace lgp 10.2 in the field.To reduce the probability of the problem in the field until that new release is available, users should be notified about the issue and how to avoid it (i.E.Told to not use drag and drop to create fused image studies, and use the image study menus instead).A field safety corrective action was initiated on 18th may 2015 under the following reference numbers: field safety notice: 100-01-102-015, field safety corrective action: fca-eiab-0002.The bug has been corrected in a new release and a service pack which will rectify the above mentioned error was released on 15th july 2015.The manufacturer is not aware of any similar incidents with this type of medical device with a similar root cause.The medical device has been distributed to the following countries: (b)(6); united states (us).
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