Recall Z-1601-2016— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-04-14, terminated 2017-03-20. It names one FDA 510(k) clearance: K023772. Product: Syngo Dynamics; Kinetdx Picture Archiving and Communications System. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-14
- Terminated
- 2017-03-20
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.