Use cautionMedical device recall · FDA · Published September 22, 2021
da Vinci SP Surgical Systems with OS4 v4.0.0 (P4_B327) May Cause Energy Delivery Issues
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. Read more at govinfonow.com/recall/61784-da-vinci-sp-surgical-systems-with-os4-v4-0-0.
“da Vinci SP Surgical Systems with OS4 v4.0.0 (P4_B327) May Cause Energy Delivery Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61784-da-vinci-sp-surgical-systems-with-os4-v4-0-0. Based on FDA recall #Z-0419-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0419-2022%22&limit=1).
The FDA announced on Sept. 22, 2021, that Intuitive Surgical is recalling da Vinci SP Surgical systems due to a software issue that may cause an inability to deliver energy or inadvertent energy delivery. Owners should contact the company for details.
How to tell if you have it
Brand: Intuitive Surgical
Product: da Vinci SP Surgical systems
Model Name/Model Number/UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605
Model Name/Model Number/UDI: ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735
Model Name/Model Number/UDI: ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742
Software Version: OS4 v4.0.0 (P4_B327)
Quantity: 46 units
The hazard
The FDA said the issue was identified during internal engineering evaluation and may require a surgeon to resolve an injury or need moderate intraoperative intervention. Use of the affected software version may also potentially cause user frustration or a minor delay to troubleshoot.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026) and Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026).
How to tell if you have this one
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).
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your da Vinci SP system; if it matches OS4 v4.0.0 (P4_B327), it is affected.
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on next steps if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0419-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0419-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.