Z-2131-2020 Class II Ongoing
FDA device recall Z-2131-2020 was initiated by Intuitive Surgical, Inc. on August 19, 2019 and is designated Class II. Reason for recall: 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 anot… The recall status is ongoing. Affected quantity: 305 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- August 19, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305 units
Product Description
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide and South Korea.
Code Information
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.