GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled certain 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, and HD23 software MRI machines due to a safety issue with non-unique series identifiers in image headers. When these identifiers are generated by the ClariView and Screen Save features of the GVTK Viewer and exported to certain PACS systems, the image series can become incorrectly associated with wrong patient records or other series, potentially resulting in mismatched medical imaging data.
The recall affects 1,246 devices worldwide (521 in the US and 725 outside the US) across numerous countries and most U.S. states. The affected devices are identified by specific model and serial numbers listed in the recall notice. The source does not specify what remedy or corrective action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit
Reason for recall: GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit Distribution: Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, Quantity: 1,246 (521 US and 725 OUS) Lot/code info: REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 00000173038MR1 00000136104MR7 00000264553MR9 00000265096MR8 00000005532YR7 00000007097YR9 00000007556YR4 00000281841MR7 00000289583MR7 0000SGH919066P 00000013883YR4 0000SGH231PPQK 00002UA2050JKX 00002UA2400LWP 00002UA24315PT 00002UA24315PY 00002UA24315P5 00002UA24907W7 00000266797MRO 00000267189MR0 00000270550MR7 00000283466MR1 00000305180MR2 00000306054MR8 0000267533MR8A Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5 00000165805MR3 00000836BD4DE2 00000012383YR6 00000269416MR4 Not Available 00002UA2400LWN 00000284254MR0 00000287469MR1 00000304797MR4 00002UA24907WK 00000005220YR9 00002UA2420VVZ 00002UA24907YC 00002UA24907YD 00002UA2510YTL 00000287996MR3 00000934BD5E4F 00000005966YR7 00000919BD5B8F 00000285151MR7 00000275969MR4 00000286019MR5 00000288669MR5 00001008BD6522 00000PH150024A 00000280423MR5 00000283613MR8 00000288416MR1 00000289840MR1 00000291157MR6 00000297685MR0 00000012064YR2 00000012526YR0 00000013660YR6 00000013820YR6 00000015654YR7 00001052XF502C 00001052XF5068 00001105XF5017 0000SGH048S36G 0000SGH105P174 0000SGH150RLYV 0000SGH150RLYX 0000SGH201TZ0V 0000SGH203QRPF 00002UA2050JKD 00002UA2050JL0 00002UA2070RGR 00002UA211170R 00002UA2281GGK 00002UA2281GGL 00002UA22827QF 00002UA2321LKW 00002UA2400LWJ 00002UA2400LWW 00002UA24907WJ 00000026639MR2 000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.