FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
- Recall number
- Z-1916-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
- Status
- Terminated
- Initiated
- 2019-05-28
- Posted
- not on file
- Terminated
- 2023-03-31
- Reason
- The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
- Root cause
- Software design
- Action
- Urgent Medical Device Correction letters dated 5/24/19 were sent to customers.
- Quantity
- 53
- Distribution
- US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.
- Lot, serial or model codes
- Serial Number: 111379 111374 111307 111225 111313 111350 111306 111281 111323 111219 111232 111271 111351 111369 111332 111370 111266 111371 111355 111310 111308 111328 111345 111310 111319 111286 111378 111338 111236 111352 111324 111344 111233 111368 111366 111230 111299 111315 111273 111249 111373 111289 111250 111317 111333 111297 111237 111341 111367 111303 111293 111302 111277
- 510(k) numbers
- K173632
- PMA numbers
- not on file
- Product code
- JAK
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06