Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop
[RECALL]Sep 15, 2023 · Asensus Surgical · Senhance · Japan
Failure Mode
RECALL
Event Date
Sep 15, 2023
Primary Entity
Asensus Surgical
Robotic Platform
Senhance
Jurisdiction / Location
Japan
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Class I recall (Sep 15 2023): a software malfunction caused uncontrolled arm motion of the laparoscope instrument actuator, which rotated continuously in one direction after the surgeon disengaged teleoperation (critical-tissue-trauma risk; emergency stop available as mitigation). 5 US devices; cease-use until software updated to v2.7.5. No patient harm reported.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.therobotreport.com/fda-recalls-asensus-surgical-robot-due-to-unintended-movement/
https://www.therobotreport.com/fda-recalls-asensus-surgical-robot-due-to-unintended-movement/
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Details
Incident Context & FAQ
What happened in Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop?
Class I recall (Sep 15 2023): a software malfunction caused uncontrolled arm motion of the laparoscope instrument actuator, which rotated continuously in one direction after the surgeon disengaged teleoperation (critical-tissue-trauma risk; emergency stop available as mitigation). 5 US devices; cease-use until software updated to v2.7.5. No patient harm reported.
When did this incident occur?
The incident is recorded as occurring on September 15, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop?
Senhance by Asensus Surgical is the recorded robot involved in this incident at Japan.
Has anyone responded to Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop?
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 Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.