Reported Sep 23, 2015 · Terminated
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816
- Product UsageThe SC2000 ultrasound imaging system is
- intended for the following applicationsCardiac, 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
- Lot codes and dates
- Model 10433816Serial
- numbers
954 of 954 codes
400217400290400425400439400441400443400447401496401719402310402495400308400641400770401110401114401135401136401138401169401174401176401370401406401366401460401591401750401753401793401803402090402139402177402197402255402323402327402339402351402387402492402508400261400350400763400787400789400790400791400792400794400797400881400886400888400890400892400898400923
- Amount recalled
- 2039 devices
Where it was sold
- Nationwide
- GA
Why it was recalled
The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.
This product could cause temporary or reversible health problems — stop using it.
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