VacQfix™
Qfix · Model RT-4517-4079VF15M · UDI-DI 10841962119082
JAI
Prescription
10
510(k) clearances
57
Adverse events
18
Recalls
8
Facilities
Description
VacQfix Cushion 40cm x 80cm, 15L Fill
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 movements are again a |
| 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 movements are again a |
| 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 in incorrect patient |
| 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 Protura software to not |
| 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 during corrective m |
| 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 Treatment Table. Comb |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.