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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
Products Sold
All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
Intuitive Surgical, Inc. is recalling da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ due to Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026