FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Dynamics; Kinetdx Picture Archiving and Communications System
- Recall number
- Z-1601-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Dynamics; Kinetdx Picture Archiving and Communications System
- Status
- Terminated
- Initiated
- 2016-04-14
- Posted
- 2016-05-04
- Terminated
- 2017-03-20
- 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.
- Root cause
- Software design
- Action
- Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.
- Quantity
- 84 units
- Distribution
- Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K023772"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28