Reported Feb 5, 2020 · Terminated
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…
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?
- The da Vinci SP surgical
- system is made of three main componentsthe Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098
- Lot codes and dates
- The Affected Systems are
SP0022SP0023SP0024SP0025 and SP0026
- The Affected Systems are
- Amount recalled
- 5 PSCs (Units)
Where it was sold
Why it was recalled
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
This product could cause temporary or reversible health problems — stop using it.
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