Acuson NX3 (2019-01-29)

Starting date:

January 29, 2019

Posting date:

February 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69038

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  Reason
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  Affected products

Affected Products

Acuson NX3

Reason

Siemens is notifying users of a potential issue with the Acuson NX3 ultrasound system with software versions VA10A, VA10B, VA10C, VA10D, VA10E, VA10F and Acuson NX3 Elite Ultrasound System with software versions VB20A and VB20B. Internal testing revealed a situation where under specific imaging conditions during pulsed wave doppler, there is a possibility for transducers to exceed the acoustic output power (AOP) values defined in track 3 of the FDA guidance for industry and staff: information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers and the output display standard in IEC 60601-2-37. There is a remote probability that this issue may result in a burn or tissue damage from cavitation.

Affected products