Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling multiple magnetic resonance (MR) imaging system models including the Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe. The recall involves approximately 4,026 systems worldwide (1,672 in the U.S. and 2,354 outside the U.S.) with serial numbers identified in the recall notice. The problem stems from an error in the SR Viewer Reporting Tool that allows edits made to one report to be saved into incorrect reports.
This reporting tool error could result in patient information or medical findings from one MR scan being incorrectly associated with or saved to a different patient's report. The systems have been distributed across all continental U.S. states (except Rhode Island) and Puerto Rico, as well as internationally to numerous countries. The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Reason for recall: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. Distribution: Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDO Quantity: 4026 (1672 US; 2354 OUS) Lot/code info: Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272922MR6 00000273268MR3 00000273598MR3 00000273631MR2 00000273632MR0 00000274287MR2 00000274288MR0 00000274740MR0 00000274742MR6 00000274886MR1 00000274887MR9 00000275000MR8 00000275001MR6 00000275003MR2 00000275463MR8 00000275464MR6 00000275527MR0 00000275528MR8 00000275533MR8 00000275534MR6 00000275535MR3 00000275536MR1 00000275537MR9 00000275538MR7 00000275539MR5 00000276137MR7 00000276164MR1 00000276184MR9 00000276196MR3 00000276197MR1 00000276241MR7 00000276242MR5 00000276243MR3 00000276244MR1 00000276245MR8 00000276457MR9 00000276458MR7 00000276461MR1 00000276637MR6 00000276656MR6 00000276657MR4 00000276658MR2 00000276659MR0 00000276660MR8 00000276676MR4 00000276678MR0 00000276680MR6 00000277441MR2 00000277442MR0 00000277443MR8 00000277444MR6 00000277531MR0 00000277533MR6 00000277534MR4 00000277535MR1 00000277639MR1 00000277640MR9 00000277642MR5 00000277643MR3 00000277780MR3 00000277782MR9 00000277916MR3 00000277917MR1 00000277918MR9 00000277919MR7 00000278037MR7 00000278038MR5 00000278040MR1 00000278041MR9 00000278101MR1 00000278102MR9 00000278104MR5 00000278105MR2 00000278164MR9 00000278167MR2 00000278219MR1 00000278221MR7 00000278312MR4 00000278313MR2 00000278315MR7 00000278389MR2 00000278390MR0 00000278391MR8 00000278392MR6 00000278552MR5 00000278553MR3 00000278554MR1 00000278555MR8 00000278556MR6 00000278605MR1 00000278606MR9 00000278607MR7 00000278672MR1 0
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.