Reported Apr 17, 2024 · Ongoing
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
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 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Patient Cart
- Part380601, a component of the da Vinci SP Surgical System
- ModelSP1098
- Lot codes and dates
- Part/UDI-DI380601/00886874114605
- SP1098 Serial Numbers
SP0202SP0253SP0254SP0219SP0228SP0231SP0238SP0273SP0208SP0226SP0240SP0247SP0249SP0256SP0257SP0268SP0270SP0272SP0221SP0223SP0225SP0229SP0230SP0232SP0233SP0235SP0236SP0237SP0239SP0241SP0242SP0243SP0244SP0245SP0248SP0250SP0251SP0252SP0255SP0258SP0259SP0260SP0261SP0262SP0263SP0264SP0265SP0266SP0269SP0274SP0278SP0280SP0282
- Amount recalled
- 53
Where it was sold
Why it was recalled
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
This product could cause temporary or reversible health problems — stop using it.
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