Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory
[RECALL]Sep 22, 2021 · Zimmer Biomet · ROSA · France
Failure Mode
RECALL
Event Date
Sep 22, 2021
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Class I recall (urgent correction Sep 22 2021; FDA Class I designation Nov 2021): on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke/serious-injury risk). 119 US devices; 3 complaints (one inaccurate electrode placement); no injuries reported. Software corrective update rolled out 2022.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.fiercebiotech.com/medtech/zimmer-biomet-issues-class-i-recall-rosa-one-robotic-neurosurgery-platform-due-to-software
https://www.fiercebiotech.com/medtech/zimmer-biomet-issues-class-i-recall-rosa-one-robotic-neurosurgery-platform-due-to-software
- Inspect Filing
https://www.beckersspine.com/robotics/zimmer-biomet-recalls-surgical-robot/
https://www.beckersspine.com/robotics/zimmer-biomet-recalls-surgical-robot/
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Details
Incident Context & FAQ
What happened in Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?
Class I recall (urgent correction Sep 22 2021; FDA Class I designation Nov 2021): on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke/serious-injury risk). 119 US devices; 3 complaints (one inaccurate electrode placement); no injuries reported. Software corrective update rolled out 2022.
When did this incident occur?
The incident is recorded as occurring on September 22, 2021 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?
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 Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.