Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling the Mavig Monitor Suspension System, Model GD60, which is contained in several fluoroscopic imaging systems including Advantx and INNOVA models. The recall was prompted by a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. Approximately 2,111 units are affected by this recall, with 1,078 distributed in the United States (including Guam and Puerto Rico) and 1,033 distributed outside the United States across numerous countries worldwide.
The recalled systems are identified by specific manufacturing lot numbers and serial numbers listed in the recall documentation. The source document does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
Reason for recall: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. Distribution: Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indo Quantity: 2,111 (1078 US; 1033 OUS) Lot/code info: Mfg Lot or Serial #/System ID, 1003/219326IN41, 20116/573632CRA, 30173/229434INNOV, 9110080/502587LAB4, 40410078/904276SP, 50410007/703689LCA2, 100300002/315448RM2, 104100042/650369SV5, 104100047/810342A41, 104100051/573632CRC1, 104100057/843674INNOVA, 106100046/603669ELCV, 110300023/315448RM1, 110310015/724656ANG, 110420162/251435I12, 120310008/804285CATH2, 123100037/617789IN1, 204110049/513861INNOVA, 204110065/623848LAB1, 304110059/908522CATH2, 304110070/519663INNOVA2, 304110071/850494WSP1, 404110063/903CSM4100, 404110077/808547QCV1A, 404110079/985867INNOVA2, 504110085/5094744100, 704120114/904202SP1, 704120117/619340VA8, 909110081/570969CATH, 1003100012/972335LIB, 1103100019/904202CATH2, 1103100026/315448RM3, 1104120128/812283IN20, 1203100022/702616INNOVA, 1203100032/515263IL4100, 1204130176/412623LAB3, 1204130198/918744JC4100, 1204930184/803329CL31, 000000007U0099/083016802100337, 00000007C20164/2706080, 00000007C20229/0835160022, 00000007C20367/MA1251VA01, 00000007C20369/00065VAS01, 00000007C20385/BY4066VA01, 00000008C20099/PK1301VA01, 00000008C20145/RU3105VA01, 00000008C20279/RU3935VA01, 0000000DUMMY12/DZ1060VA01, 0000000DUMMY16/B5811426, 0000000DUMMY20/NG1049VA01, 000000106/4051/617636CL1, 00000014926VE0/08301628448937, 00000018518VE1/0835160019, 00000024110061/S4160056, 00000025022VE5/083016007351458, 00000026276VE6/0835160016, 00000039475VE9/0850060688, 000000404/0067/239436CATH1, 000000408/0047/610645LAB10, 000000408/0048/281637SL3131, 000000408/6023/ECXV1406C, 0000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.