Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 8/52015
Class lI:
PRODUCT
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Recall Number Z-2321-2015
REASON
Potential measurement error on your ACUSON S Family ultrasound system when repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position. of the shear velocity data.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountainview, CA on 6/25/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
629 units
DISTRIBUTION
Nationwide and Internationally
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