GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled its Advantage Workstation software, including Volume Viewer Plus 5.x (Advantage Workstation 4.2), Volume Viewer 3.x (Advantage Workstation 4.1), and Volume Analysis (Advantage Workstation 4.0), due to potential safety issues that could result in incorrect views and measurements. A total of 363 units were distributed worldwide, including across numerous U.S. states and countries such as Canada, China, Germany, Japan, Mexico, and others.
The recall document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
Reason for recall: Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis. Distribution: Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUG Quantity: 363 Lot/code info: 000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS 000000010048GS 000000010067GS 000000010063GS 000000010087GS 000000010034GS 000000010083GS 000000010036GS 000000010080GS 000000010044GS 000000010006GS 000000010068GS 000000010027GS 000000010091GS 000000010032GS 000000010029GS 000000010078GS 000000010007GS 000000010013GS 000000010090GS 000000010065GS 000000010016GS 000000010055GS 000000010069GS 000000010076GS 000000010052GS 000000010025GS 000000010092GS 000000010070GS 000000010089GS 000000010046GS 00000LEE1BC41D 000000010042GS 000000010061GS 000000010066GS 00000L0236B9CE 00000LEE1BC908 00000L023A0E34 00000L02019460 00000L02019ABA 00000L025B5C0C 00000LEE17087C 00000L610029DF 00000LEE1A72F8 00000L02374674 00000L025871B4 00000LEE1AA670 00000L6100BCF6 00000L61009728 00000L02167EAD 00000LEE1AD7CE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.