Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120

FDA device recall Z-2418-2020 · posted 2020-06-23 · Open, Classified

Recall details

Recalling firm

Hocoma AG

Reason for recall

The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.

Action taken

The firm began notifying affected customers on June 8, 2020. Customers were informed that the motor-controller in their Lokomat may fail, potentially leading to an unintended error in functionality of the Body Weights Support Rope which means that the rope can go up or down in an uncontrolled way. To minimize a risk in relation to a potential failure of the motor-controller, the firm advises you to do the following: - As indicated in the Instruction for Use, permanently monitor patients, which perform a training with the Lokomat. The scenario is especially critical for pediatric patients. - In any case of unusual behavior of the Body Weight Support Rope (e.g. the rope goes up unintendedly) immediately press the Emergency button on the handrail or on the Tele Stop in order to stop the treadmill and the orthosis. Immediately afterwards switch off the power supply in order to stop the rope going up. Afterwards release the patient with the emergency release knob. See Details attached. - Make sure that all possible users of the Lokomat in your institution are informed of this temporary precautionary approach. The firm will continue to work on a technical solution to further minimize the risk of the potential motor control failure.

Root cause

Device Design

Status

Open, Classified

Product code

IKK

Quantity affected

494

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.

Date initiated

2020-06-08

Date posted

2020-06-23

Location

Volketswil, Switzerland