SafeGait 360 Balance and Mobility Trainer
DIH TECHNOLOGY INC. · Model SG360 · UDI-DI 00860012112814
Description
SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
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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