ZeroG 3D 3-Dimensional BWS System
ARETECH, LLC · Model ZG3D-001 · UDI-DI 00850018836265
Description
ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-01 | Btt Health Gmbh | Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic |
| 2019-07-29 | MOTEK MEDICAL B.V. | The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu |
| 2013-06-12 | Accelerated Care Plus Corporation | An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. |
| 2012-11-12 | BioMotion Medical Systems, LLC | BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin |
| 2011-07-15 | Alter-G, Incorporated | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
| 2009-05-27 | Hocoma AG | Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation |
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