4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens Medical Solutions USA, Inc. Bus

FDA device recall Z-0826-2011 · posted 2010-12-28 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.

Action taken

SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware. If you have any questions, please contact (650) 969-9112 or (800) 422-8766.

Root cause

Other

Status

Terminated

Product code

IYN

Quantity affected

196 units both Transducer and ACUSon SC2000

Distribution

Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Po

Date initiated

2010-09-29

Date posted

2010-12-28

Date terminated

2011-10-04

Location

Mountain View, CA

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