CLASS II ONGOING Device recall · Reported 1 Jul 2020 · FDA Enforcement Report
Lokomat Pro recalled by Hocoma AG
Hocoma AG is recalling Lokomat Pro, distributed nationwide in the US. The recall was initiated on 8 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2418-2020
- FDA event ID
- 85857
- Recalling firm
- Hocoma AG, Volketswil, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jun 2020
- FDA classified
- 23 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 8 Jun 2020 | Recall initiated by company | |
| 23 Jun 2020 | Classified by FDA | +15 days |
| 1 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.
Nationwide FloridaGeorgiaIllinoisMichiganMinnesotaMissouriNebraskaNew YorkTexas
Questions about this recall
Is Lokomat Pro recalled?
Yes. Hocoma AG recalled Lokomat Pro on 8 Jun 2020. The recall is Class II and its status is Ongoing. Recall number Z-2418-2020.
Why was it recalled?
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.
Which lots are affected?
All units
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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