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Siemens Medical Solutions USA, Inc. recalls Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 1043420
Recalled April 17, 2013 · FDA recall Z-1081-2013 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
120 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →