Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 8/52015
Class lI:
PRODUCT
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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-2314-2015
REASON
Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
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
1789 units
DISTRIBUTION
Nationwide and Internationally
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