Prestilix 1600X Prestilix system is a fully integrated recall
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology…
Why was Prestilix 1600X Prestilix system is a fully integrated recalled?
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 825 (38 US and 787 OUS) in total
- Distribution
- 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.
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)