FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci SP surgical system
- Recall number
- Z-2260-2020
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci SP surgical system
- Status
- Terminated
- Initiated
- 2019-04-01
- Posted
- 2020-06-03
- Terminated
- 2021-12-16
- Reason
- Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
- Root cause
- Software design
- Action
- The firm sent a letter to consignees on April 1, 2020 stating that an Intuitive representative will schedule a site visit to provide a software update as soon as possible. Firm representatives will be available by phone to answer any questions related to this Medical Device Correction. Actions taken by the customer are to: Inform all personnel who are involved with the affected device at your site of the following instructions: 1.If vibrations are sensed at the instrument and/or endoscope tips in Adjust Mode and the instrument arm is near its vertical limit: a.Cease applying sustained force against the hand control haptic feedback, b.Exit Adjust Mode by releasing the Endoscope Control pedal c.Exit following mode by removing your head from the Surgeon Console, or d.Press the Emergency Stop button. Any of these actions will stop the vibration. 2.If mechanical vibration persists, discontinue use of the system and contact Technical Support. 3.Inform affected personnel when the software update has been completed by the Intuitive representative. 4.Complete the attached Acknowledgment Form and return it via fax or email to Intuitive as instructed on the form. 5.Please retain a copy of this letter and the acknowledgment form for your files. Customers with additional questions: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST); South Korea: + 82-02-3271-3200, Opt. 3 (9 AM to 6 PM KSTJ)
- Quantity
- 17
- Distribution
- U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
- Lot, serial or model codes
- Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
- 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