GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Ve
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling Advantage Workstations (versions 4.2 and 4.3) with Volume Viewer 2 (versions 6.4-6.8) that include Advance Vessel Analysis software. The devices produce incorrect measurements when using the Aorta analysis protocol or customized protocols for aneurysm analysis. Additionally, a second issue was discovered where PET data loaded into the Volume Viewer may have missing slices in a PET series. Approximately 1,055 units have been distributed worldwide, including throughout the United States and multiple international locations.
Until a new software version is installed, GE Healthcare is instructing users not to use the aorta analysis protocol or customized protocols for aneurysm analysis on affected devices. The recall notice does not specify what action affected consumers should take beyond this instruction.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
Reason for recall: GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie Distribution: Worldwide Distribution - US (nationwide) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA, PR, SC, SD, TN, TX, VA, WA, WV, WI and the countries of YUGOSLAVIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA Quantity: 1055 Lot/code info: FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029FDB24 A4194418 0000002A8C1D3 ws132201 0000002AB15AF PL1008AW03 00000L0201354A RJ0005 00000L02013776 HC9074AW01 00000L02013900 00137ADW03 00000L020140F4 10146ADW01 00000L02014128 PPR83607 00000L02014228 082421060040AW 00000L0201485E 813642AW42 00000L0201492C 864366AAW 00000L020149E4 083055065231713 00000L02014C1C 2526577 00000L0201521E 26329AW2 00000L02019460 617355AW3 00000L020194E0 919660AWMRI 00000L020195D0 352CDCAW43 00000L02019690 809780AW2 00000L02019696 510295ANAW 00000L020197FE 2535997AW42 00000L020198A8 WS98556 00000L02019944 706774AW2 00000L02019946 716887AW2 00000L0201994E 716887AW1 00000L02019A02 EG1277AW01 00000L02019ABA 617355AWPC1 00000L02019AE8 850475PAW 00000L0202AC34 082416310006AW 00000L0202AEB4 600160AW01 00000L0202AECA 083055822100526 00000L0202B4AA CC4400AW03 00000L0202B4B8 083049062634502 00000L0202B4BF 083049802101529 00000L0202B4C2 0920559053AW1 00000L0202B4D2 B5298307 00000L0202B52F TN1270AW01 00000L0202B53F TN1273AW01 00000L0202B5BA 900010AW20 00000L0202B639 00860ADW04 00000L0202B668 082421190132AW 00000L0202B677 0910553081AW1 00000L0202B678 082421100352AW 00000L0202B6AE A5251313 00000L0202B773 DPB15840 00000L0202B774 082416040018AW 00000L0202B786 EE672841 00000L0202B7D6 X185801202 00000L0202B7D9 RU1106AW04 00000L0202B7EC 083049202100256 00000L0202B7EE 0853550270 00000L0202B82F RU1834AW01 00000L0202B834 0850270206AW1 00000L0202B84F 00010DCS01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.