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