medical Class II Updated 2019-06-19

GE Healthcare, LLC recalls Prestilix 1600X Prestilix system is a fully integrated

Recalled Product

Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.

Hazard / Issue

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 010120RX03; 030024RX09; 030047RX02; 030077RX01; 030083RX09; 030106RX09; 030236RX01; 030259RX02; 030557RX01; 040059RX04; 040092RX01; 040200RX04; 0779; 080083RX11; 110018RX01; 12916PREST; 130015RX03; 130136RX01; 130156RX01; 13517PREST; 160113RX01; 160163RX02; 18410PREST; 190052RX05;190083RX01; 200023RX01; 220117RX03; 250142; 306694RF1; 330016; 38132PREST16; 540009; 62442; 73113PTX16; 880001; 918744JF24; 932031001; 95634; 96408; A1092508; A1098606; A1187501; A1411504; A1588501; A1588509; A1607005; A1876201; A1876207; A1898508; A2326001; A4463308; A5118521; A5167917; A5167918; A5170718; A5190924; A5298404; A5306801; A5309805; A5326901; A5487203; A5526302; A5580605; A5604818; A5802707; A5803502; A5810809; A5816105; A5816604; A6014503; AH5205XR01; AH7412XR02; B1249603; B1737601; B5804408; B5811903; C1607003; C1661404; C1669608; C1692202; C9222107; C9956806; CC1498XR01; CEZ08001; D1242801; DE649909; DPE73910; DZ1041RX01; E4644006; EE672818; F2485201; FE387802; FEG48312; GF1009RX02; GP1030RX01; HU1006RX01; LB1001RX01; M1001901; M1035102; M1053501; M1054509; M1074303; M1076827; M1122201; M1130909; M1142502; M1198104; M1199106; M1249606; M1299803; M1313401; M1385401; M1399101; M1413609; M1416106; M1429108; M1435107; M1455808; M1477106; M1492702; M1501904; M1578905; M1584606; M1758601; M1796306; M1919206; M2271506; M2324818; M2324903; M2364507; M2425202; M2503018; M2616710; M2616713; M2842312; M2847101; M2864106; M4031051; M4033051; M4037046; M4472903; M4496205; M4499502; M4503501; M6024001; M6025606; M6025607; M6036204; M6069007; M6076801; M7405602; M9200405; M9409524; M9708009; M9866204; M9868002; M9886619; MA1002RX01; MA1014RX02; MPX35402; NEV12301; NP384101; P6006301; PC0088XR01; PC0490XR01; PER09100; PF1002RX01; PMR25200; PP7281XR02; SK1008RX01; TN1002RX01; TN1006RX01; TN1010RX01; TN1040RX01; TN1044RX01; X88000101; and YE626907.
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