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
- Recall Number
- Z-1081-2013
- Event Number
- 64855
- Firm
- Siemens Medical Solutions USA, Inc.
- FEI Number
- 2936884
- Product Code
- IYN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 28, 2013
- Posted
- April 10, 2013
- Terminated
- February 14, 2014
- Address
- 685 E Middlefield Rd, Mountain View, CA, 94043-4045
Description
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.
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.
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.
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.
120 units