Recall Z-1200-2018— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1200-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-03-05, terminated 2021-02-26. It names one FDA 510(k) clearance: K170315. Product: ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.. Reason: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-05
Terminated: 2021-02-26
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170315 — Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.·cleared 2017-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.