Adaptix Ortho350
ADAPTIX LIMITED · Model AD01-0850 · UDI-DI 05061068070003
Description
The Adaptix Ortho350 (K252133) is a 3D tomographic X-ray device intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device comprises of an Ortho350 C-Arm Assembly and a Control PC. It is also possible to create 2D X-ray images of the desired anatomy. The Adaptix Ortho350 device is a portable system that can be placed on a benchtop or the floor or mounted on an optional cart for added mobility. To obtain 3D tomosynthesis images, the relevant area of the patient is positioned against the detector cover then X-rays are emitted from a controlled sequence of locations. The system uses a low-power, monoblock X-ray source with integrated controls and feedback, synchronized electronically with the detector for tomosynthesis image acquisition. The system is operated by an X-ray technologist or suitably qualified healthcare professional using and designed with safety features to only allow X-ray emission when multiple controls are in place.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-18 | AGFA Healthcare Corp. | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation whe |
| 2020-02-10 | Agfa N.V. | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2003-04-15 | Siemens Medical Solutions USA, Inc | the back up safety catch may not function properly |
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