Reported Jan 5, 2022 · Ongoing
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci SP Surgical systems with the following
- Model Name/ Model Number / UDIASSY,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
- Lot codes and dates
- All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
- Amount recalled
- 46
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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