Stryker Mako Total Knee software correction over 'error #3' codes when switching applications
[RECALL]May 28, 2024 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
RECALL
Event Date
May 28, 2024
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Voluntary software correction (announced ~May 28 2024; Class 2): increased 'software error #3' codes when switching between the total-knee and total-hip applications without a shutdown/restart, risking loss/deterioration of robotic function, surgical delay, or conversion to manual. Mitigation = shutdown/restart before switching apps. Cap-flag: exact units/Z-number not captured; other Mako accessory Class-2 recalls exist (handpiece, tracking kits, saw attachment) not individually verified here.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.massdevice.com/stryker-warns-software-error-mako-surgical-robot/
https://www.massdevice.com/stryker-warns-software-error-mako-surgical-robot/
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Details
Incident Context & FAQ
What happened in Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
Voluntary software correction (announced ~May 28 2024; Class 2): increased 'software error #3' codes when switching between the total-knee and total-hip applications without a shutdown/restart, risking loss/deterioration of robotic function, surgical delay, or conversion to manual. Mitigation = shutdown/restart before switching apps. Cap-flag: exact units/Z-number not captured; other Mako accessory Class-2 recalls exist (handpiece, tracking kits, saw attachment) not individually verified here.
When did this incident occur?
The incident is recorded as occurring on May 28, 2024 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
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 Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.