FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
- Recall number
- Z-2131-2020
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
- Status
- Open, Classified
- Initiated
- 2019-08-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- Urgent Medical Device Recall Letters (Field Safety Notices) were hand-delivered to U.S. customers on August 19, 2019 and OUS customers on August 20, 2019. Customers were asked to locate affected camera(s) in their inventory and inspect per the instructions attached to the Field Safety Notice throughout the life of the camera(s). If residual soil is present, customers were to return the affected camera(s) to the manufacturer using the standard Return Materials Authorization (RMA) process. Additionally, customers were requested to: iInform necessary hospital personnel about this issue; complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form; and to retain a copy of this letter and the Acknowledgement Form for their files. Customers were informed that an Intuitive Representative would schedule a site visit to review the attached inspection instructions, and that the firm will provide a replacement camera, at no charge, for returned affected product. Customers requiring further information or support may contact their Clinical Sales Representative or contact Intuitive Customer Service at the following numbers: US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com, or South Korea Customer Service: + 82-02-3271-3200, Option 3 ( 9AM to 6 PM KSTJ)
- Quantity
- 305 units
- Distribution
- Distribution US nationwide and South Korea.
- Lot, serial or model codes
- Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
- 510(k) numbers
- ["K173906"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28