FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
- Recall number
- Z-0419-2022
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
- Status
- Open, Classified
- Initiated
- 2021-09-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
- Root cause
- Software design
- Action
- On 09/22/2021, the firm notified affected customers via mail of "Urgent Medical Device Correction - ISIFA2021-04-C." The letter indicated, "As part of the field action process, please complete the actions below: 1. Ensure that all personnel who use the da Vinci SP System read and understand the contents of this letter. 2. Inform the personnel when the software update has been completed by the Intuitive representative. 3. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for your files. 5. Contact Technical Support at the number listed below for assistance if you have experienced this issue: US Technical Support: 800-876-1310, Option 1 (24/7) An Intuitive representative will schedule a site visit to install the next available software update. If you require further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: -US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com."
- Quantity
- 46
- Distribution
- US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.
- Lot, serial or model codes
- All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
- 510(k) numbers
- ["K173906","K182371","K192717","K202968","K211316","K211595"]
- 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