15

Sep

1998

GE Advantx Vascular Imaging Class II 1917 units

0

GE Advantx Vascular Imaging Systems, angiographic X-ray systems: a) GE Advantx Vascular Imaging

Systems (DX and DLX) with Stenosis Analysis Software and;

b) Cardiac Review Stations (CRS) with Quantitative Analysis Software. Safety Alert #N-002/003-9.

REASON

When procedures in the Operator Manual for stenosis sizing are not followed each time a time
measurement is taken, serious injury can result.

CODE

GE Advantx Vascular Imaging Systems (DX and DLX) with Stenosis Analysis Software. The model
numbers of the systems which could have this software are 45313940:DX V4 512, 45313950:DX V4
1024, 45323960:DX V4 512C, 45474120: DX HL 1024, 45474121:DX HL 512C, 45474122:DX HL
512C, 45561420:DX HL Biplane, 2105044:DX HL to DLX, 2102748:DLX2, 2102748:DLX2,
2128315:DLX3, 2128636:DLX3, 2147925:DLX3, 2147926:DLX3, 2182670:DLX3, 2182671:DLX3,
2182672:DLX3, and 2182673:DLX3. Devices with Stenosis Analysis Software and Quantitative
Coronary Analysis Software are affected.

MANUFACTURER

GE Medical Systems – Europe, Buc Cedex, France.

ALERTED BY

General Electric Company, Waukesha, Wisconsin, by letter dated September 1998.

DISTRIBUTION

Nationwide and international.

QUANTITY

1,917 units were distributed.

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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