Recall Z-1753-2019
GE Healthcare, LLC · initiated March 29, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
Reason for recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
FDA-determined cause: Device Design
Action taken
On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-1753-2019
- Initiated
- March 29, 2019
- Posted by FDA
- June 10, 2019
- Terminated
- April 15, 2021
- Product code
- KXJ – Table, Radiologic
- 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…
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1751-2019 Class II | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose…There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount… | 03/29/2019Terminated |
| Z-1752-2019 Class II | Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a…There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount… | 03/29/2019Terminated |
| Z-1754-2019 Class II | Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal…There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount… | 03/29/2019Terminated |
| Z-1755-2019 Class II | Silhouette VR This fully integrated system offers intuitive controls with advanced…There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount… | 03/29/2019Terminated |