Home › Device types › JAI
Couch, Radiation Therapy, Powered
FDA product code JAI · Class 2 · Radiology
349
Registered devices
57
Adverse events
18
Recalls
32
510(k) clearances
Devices with this code
InfinityLock™ — QfixFlexLock™ — QfixVacQfix™ — QfixProutra™ — MEDTEC, INC.VacQfix™ — QfixEncompass™ — QfixAirShuttle Transfer Handle — QfixQUANTUM™ CT Overlay — QfixFlexLock™ — QfixInfinityLock™ — QfixAccess™ Supine — QfixEncompass™ SRS Fibreplast™ System — QfixStradivarius™ — QfixHead and Neck Overlay, iBeam Compatible — Aktina Corp.VacQfix™ — QfixStradivarius™ — QfixProtura 1.7.0 — MEDTEC, INC.VacQfix™ — QfixVacQfix™ — QfixZiFix™ — QfixQUANTUM™ CT Overlay — QfixEncompass™ SRS Fibreplast™ Anterior Mask — QfixVacQfix™ — QfixHand Grips, Elekta Compatible — Aktina Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-06 | LEONI CIA CABLE SYSTEMS | Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the m |
| 2023-10-06 | LEONI CIA CABLE SYSTEMS | Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the m |
| 2018-05-16 | Elekta, Inc. | Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting i |
| 2017-11-08 | Med Tec Inc | When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Pro |
| 2017-09-05 | Forte Automation Systems Inc | Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator. |
| 2016-03-31 | Med Tec Inc | When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters. |
| 2015-01-29 | Elekta, Inc. | It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed |
| 2014-04-17 | Elekta, Inc. | If screws are not properly tightened with a torque wrench they may become loose over time. |
| 2013-12-05 | Siemens Medical Solutions USA, Inc | Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT T |
| 2013-03-27 | Accuray Incorporated | A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. |
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