16
May
2018

Recall – Ultrasound system error due to EMI

0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/16/2018
Class II:

PRODUCT
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.. Recall Number: Z-1200-2018

REASON
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountain View, CA on 3/5/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
229 systems

DISTRIBUTION
Nationwide and internationally

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