Reported Jun 10, 2020 · Terminated
da Vinci SP surgical system
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci SP surgical system
- Lot codes and dates
- Serial Numbers
SP0022SP0031SP0023SP0032SP0024SP0034SP0025SP0035SP0026SP0036SP0027SP0037SP0028SP0038SP0029SP0039SP0030
- Serial Numbers
- Amount recalled
- 17
Where it was sold
Why it was recalled
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
This product could cause temporary or reversible health problems — stop using it.
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