da Vinci SP Camera recall
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Why was da Vinci SP Camera 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
- Product
- da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 305 units
- Distribution
- Distribution US nationwide and South Korea.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)