FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug
[RECALL]May 27, 2009 · Hocoma · Hocoma Lokomat · Global
Failure Mode
RECALL
Event Date
May 27, 2009
Primary Entity
Hocoma
Robotic Platform
Hocoma Lokomat
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82522
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82522
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Details
Incident Context & FAQ
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.