ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is int

FDA device recall Z-1056-2015 · posted 2015-02-05 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.

Action taken

Siemens Medical sent an Customer Safety Advisory Notification to all affected customers on January 12, 2015 , via Certified mail, return receipt requested.The letter identified the product the problem and the action needed to be taken by the customer. At this time there is not mitigation to avoid risk associated with this issue. Local Customer Service Engineers will be contacting each site to replace the console. Until the necessary repairs have been completed, please share the information with all uses of the device. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a very high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.

Root cause

Component design/selection

Status

Terminated

Product code

IYN

Quantity affected

230

Distribution

Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeri

Date initiated

2015-01-12

Date posted

2015-02-05

Date terminated

2015-11-12

Location

Mountain View, CA

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