Device product
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Z-1601-2016
Product summary
- Event
- Event 73907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-1601-2016
Official wording
Reason: Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
Code information: Model Numbers: 10091637, 10091673, 10091805, 10091807 Serial Numbers: 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185, 85186, 85189, 85191, 85234, 85235, 85239, 85281, 85307, 85309, 85322, 85325, 85326, 85329, 85335, 85338, 85350, 85353, 85354, 85368, 85370, 85374, 85377, 85380, 85385, 85387, 85401, 85418, 85421, 85422, 85427, 85435, 85442, 85447, 85462, 85467, 85468, 85469, 85470, 85473, 85481, 85482, 85484, 85859, 85860, 85866, 85867, 85871, 85872, 85873, 85874, 85875, 85876, 85880, 85883, 85884, 85893, 85896, 85910, 85918
Distribution pattern: Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
Derived failure modes
-
Unknown
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.