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Incident · Recall

FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug

Hocoma issued a field safety notice for the Lokomat System with Pediatric Module (software versions V4.30 through V5.0x) after discovering that changes to stored sensitivity values could lead to higher limits in force and trajectory deviation. 7 units were distributed across IL, MA, MI, NY, and OH.

The FDA classified this as a Class 2 recall. Hocoma sent instructions to users to avoid problems and asked them to return a declaration acknowledging the notice.

Occurred 2009-05-27 · Hocoma Lokomat at Global · Hocoma · Global · Exoskeletons · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug

Machine-readable surfaces

Sources (1)

  1. Class 2 Device Recall LokomatSystem · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82522 · 2010-01-07

Common questions

What happened in FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug?
Hocoma issued a field safety notice for the Lokomat System with Pediatric Module (software versions V4.30 through V5.0x) after discovering that changes to stored sensitivity values could lead to higher limits in force and trajectory deviation. 7 units were distributed across IL, MA, MI, NY, and OH. The FDA classified this as a Class 2 recall. Hocoma sent instructions to users to avoid problems and asked them to return a declaration acknowledging the notice.
When did this incident occur?
The incident is recorded as occurring on May 27, 2009 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug?
Hocoma Lokomat by Hocoma is the recorded robot involved in this incident at Global.
Has anyone responded to FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-07-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug.

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Canonical ID 7d721484-e29c-4319-b46a-0ab954cee00e