Z-2418-2020Class II

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

Name: Z-2418-2020 Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005...
Creator: Hocoma AG
Published: 2020-06-08
License: https://open.fda.gov/license/

Hocoma AG / initiated 2020-06-08 / Open, Classified / root cause: design

FDA source

Hocoma AG began a recall of Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE... on 2020-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2418-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-08
Posted: 2020-06-23
Recalling firm: Hocoma AG
Product: Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system
Product code: IKK System, Isokinetic Testing And Evaluation
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 494
Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.
Product codes and lots: All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2418-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2418-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-23

Product code IKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)