Reported Jun 3, 2020 · Ongoing
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
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 Camera; PN 430060-33
- Model Number430060-33. For endoscopic surgery
- Lot codes and dates
- Model Number430060-33
- UDI Number00886874114384; All serial numbers
- Amount recalled
- 305 units
Where it was sold
- Nationwide
Why it was recalled
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
This product could cause temporary or reversible health problems — stop using it.
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