FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
- Recall number
- Z-1081-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
- Status
- Terminated
- Initiated
- 2013-03-28
- Posted
- 2013-04-10
- Terminated
- 2014-02-14
- Reason
- When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
- Root cause
- Device Design
- Action
- Siemens Medical Solutions USA Inc. sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A return response form is included for customers to complete and mail to the recalling establishment. Siemens stated additional follow up action will occur, once material is available, where Siemens field service engineers will visit each unit and replace the affected MPI 4 board. For further questions please call (650) 694-5747.
- Quantity
- 120 units
- Distribution
- Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.
- Lot, serial or model codes
- All units of this model.
- 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