Recall Z-0825-2014— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0825-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2013-12-22, terminated 2015-03-05. It names one FDA 510(k) clearance: K123622. Product: ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.. Reason: The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-22
Terminated: 2015-03-05
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123622 — ACUSONSiemens Medical Solutions USA, Inc.·cleared 2012-12-05

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 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.

Reason for recall

The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.

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