Hocoma Lokomat Pro Recalled for Uncontrolled Body Weight Support Rope Movement
Hocoma AG is recalling 494 Lokomat Pro units because a motor controller failure may cause the body weight support rope to move up or down in an uncontrolled way.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the body weight support rope may move in an uncontrolled way, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Hocoma AG is recalling 494 units of the Lokomat Pro, a medical device intended to support treadmill training for patients with walking disabilities. The recall covers specific catalog numbers including 30003, 30004, 30005, 30683, 30684, and 32001. The devices were distributed worldwide and nationwide in the United States, including in Florida, Georgia, Illinois, Michigan, Minnesota, Missouri, Nebraska, New York, and Texas.
The recall is being conducted because the motor controller may fail. This failure can potentially lead to an error in the functionality of the Body Weights Support Rope, causing the rope to move up or down in an uncontrolled manner. The source text does not report any specific injuries or illnesses associated with this defect.
Consumers and healthcare facilities should stop using the affected Lokomat Pro units immediately. Users should contact Hocoma AG for instructions on how to resolve the issue or obtain a replacement, as directed by the manufacturer.
The recalled product
- 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…
- Manufacturer
- Hocoma AG
- Affected units
- 494
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units
Distribution
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