Reported Mar 21, 2018 · Terminated
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following…
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 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
- Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823
- Serial numbers involved areand 403882
563 of 563 codes
400154400173400201400252400278400294400355400423400497400518400606400614400655400761400836400840400888400899400909401173401186401195401207401230401246401254401259401289401361401367401377401423401429401443401444401451401452401454401455401491401494401501401546401561401565401567401569401572401577401580401589401603401604401606401607401612401627401643401649401654
- Amount recalled
- 564 systems
Where it was sold
- Nationwide
Why it was recalled
The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
This product could cause temporary or reversible health problems — stop using it.
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