Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems

FDA device recall Z-1961-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.

Action taken

The firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available. Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.

Root cause

Software design

Status

Terminated

Product code

ITX

Quantity affected

2591 units

Distribution

Worldwide distribution.

Date initiated

2009-03-21

Date posted

2011-04-12

Date terminated

2012-03-09

Location

Mountain View, CA

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