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Recall Observatory FDA recall evidence

Device 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.

Z-1753-2019

March 29, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 82668
Status
Terminated
Classification
Class II
Quantity
825 (38 US and 787 OUS) in total
Official record key
device-enforcement:Z-1753-2019

Official wording

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

Code information: 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.

Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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