Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 7/12/2017
Class lI:
PRODUCT
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 — Programmable diagnostic computer,
Recall Number Z-2688-2017
REASON
Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or- information from different examinations of the same patient being combined into one report. — The error causes information from two examinations to be combined into one report.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 5/16/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US: 13 units
DISTRIBUTION
US Distribution to the states of : IN, MI, IA
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