FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
- Recall number
- Z-0052-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
- Status
- Terminated
- Initiated
- 2013-07-10
- Posted
- 2013-10-23
- Terminated
- 2013-11-25
- Reason
- Software issue results in inaccurate 3D image may result in ablation in wrong location.
- Root cause
- Device Design
- Action
- Siemens sent an Customer Safety Advisory Notification letter to all affected customers on July 10, 2013.The letter identified the product the problem and the action needed to be taken by the customer Letters provide steps to mitigate the risk and inform users that a software fix will be installed as soon as it is available. Siemens Service Engineers will contact all locations to arrange installation once fix is available. All personnel who use the ACUSON should be notified of the issue. Update September 17, 2013 : After discussion with CDRH, Siemens revised their letter to state that procedures using the ACUSON SC2000 system with BioSense Webster CARTO 3 equipped with CARTOSOUND Module and SoundSTAR Catheter should not be performed until the users system has been updated with the software upgrade that resolves the issue. For further questions please call (650) 694-5398.
- Quantity
- 26 units
- Distribution
- Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.
- Lot, serial or model codes
- Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882
- 510(k) numbers
- ["K123622"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- 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