FDA Device recall Z-1753-2019
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system
- FDA Device
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system by Ge Healthcare, citing there has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1753-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-29 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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.
Reason
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Identifiers
| code_info | 010120RX03; 030024RX09; 030047RX02; 030077RX01; 030083RX09; 030106RX09; 030236RX01; 030259RX02; 030557RX01; 040059RX04;…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; GP1030R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1753-2019%22
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