Intuitive Surgical recalls da Vinci SP Surgical systems with specific software versions that may experience energy delivery problems, requiring surgeon intervention or causing delays. Affected units include models with UDI codes listed in the recall notice.
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.
Intuitive Surgical is recalling da Vinci SP surgical systems with a specific software version that may cause energy delivery issues, potentially requiring the surgeon to resolve injuries or delays. This could impact surgical procedures if the system fails to deliver energy properly.
The system may fail to deliver energy properly during surgery, requiring the surgeon to manually address injuries or delays. This could lead to complications if the system inadvertently delivers energy in unintended ways.
Surgeons using da Vinci SP surgical systems with the affected software version (OS4 v4.0.0 P4_B327) are most at risk. The recall affects specific models and serial numbers listed in the recall notice.
Check for the model numbers and UDI codes listed in the recall notice: ASSY,PSS,SP1098,P4/ 380601-44, ASSY,SSC,SP1098,P4/ 380940-44, or ASSY,VSS,SP1098,P4/ 380941-44. Also, look for software version OS4 v4.0.0 (P4_B327).
Verify the software version on your da Vinci SP system; if it matches OS4 v4.0.0 (P4_B327), it is affected.
Reach out to Intuitive Surgical for guidance on next steps if your system is affected.
The affected software version is OS4 v4.0.0 (P4_B327).
Check for the model numbers and UDI codes listed in the recall notice: ASSY,PSS,SP1098,P4/ 380601-44, ASSY,SSC,SP1098,P4/ 380940-44, or ASSY,VSS,SP1098,P4/ 380941-44.
No, but if your system has the affected software version, contact Intuitive Surgical for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0419-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0419-2022 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
