GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW Volume
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling GSI Viewer 1.10 software on AW VolumeShare 4 (Model Numbers 5342114, 5342114-2, and 5342114-3) due to a measurement accuracy problem. When users perform a secondary capture and then change the region of interest (ROI) or zoom in on an image, the DICOM header does not update to match the new image, which can result in inaccurate line measurements.
The recall affects 283 units (59 in the US and 224 outside the US) distributed across multiple states and countries worldwide. Affected units can be identified by their manufacturing lot or serial numbers listed in the recall notice. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.
Reason for recall: When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate. Distribution: Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, a Quantity: 283 (59 US, 224 OUS) Lot/code info: Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2 00000171121GE7 00000171120GE9 00000186991GE6 00000186695GE7 00000171129GE0 00000207772GE5 00000211999GE8 00000194705GE0 00000175339GE1 00000171944GE2 00000198439GE2 00000187430GE4 00000183133HP8 00000171643GE0 00000L10106002 00000N10127001 00000V10334001 000000Z9309005 000000Z9309002 00000F10090001 00000H10153001 00000K10130001 000000G9337003 000000G9337002 00000W10230001 00000W10230002 00000H11083001 00000Y10245001 00000G10161002 00000M10162001 000000G9337001 00000180602GE5 00000187436GE1 00000171943GE4 00000194704GE3 00000194703GE5 00000194702GE7 00000175342GE5 00000187435GE3 00000172680GE1 00000171127GE4 00002UAO430KJL 00002UA04307KD 0000CZC9450FKS 0000CZC944B57J 0000CZC9385MCH 0000CZC94602P9 0000CZC94583RB 0000CZC1128HGN 0000CZC1128HGR 0000CZC1100YF8 0000CZC1128HGJ 00002UA04307L2 00002UA043
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.