17

Jul

2006

Class IIl General Electric Med. Sys.

0

Company: General Electric Med. Sys.
Date of Enforcement Report:7/12/2006
Class:lIl

PRODUCT
Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system, Recall # Z-1172-06

REASON
In the cardiac measurement section of the device the calculation of the ‘PG Mean’ (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question ‘PG Mean’ for any diagnostic or therapeutic decision, and ‘PG Mean’ values should not be included in any patient documentation.

CODE
Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction. Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction.

RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med. Sys. Ultrasound, West Milwaukee, WI, by letter on April 17, 2006.
Manufacturer: Kretziechnik Gesmbh, Zipf, Austria, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3936

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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