Reported Apr 5, 2023 · Ongoing
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
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 Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
- Lot codes and dates
- da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical
- System Model IS4200 Part Number380647
- UDI-DI Code00886874114216
- Serial Numbers
638 of 638 codes
RSK8062RSK8104RSK8128RSK8130RSK8134RSK8135RSK8136RSK8137RSK8138RSK8139RSK8143RSK8144RSK8146RSK8147RSK8148RSK8149RSK8152RSK8153RSK8154RSK8158RSK8159RSK8160RSK8162RSK8163RSK8164RSK8166RSK8167RSK8168RSK8170RSK8172SK0050SK0055SK0090SK0091SK0101SK0112SK0128SK0137SK0141SK0151SK0153SK0160SK0169SK0211SK0213SK0221SK0280SK0285SK0329SK0382SK0383SK0393SK0395SK0420SK0429SK0433SK0499SK0511SK0518SK0540
- Amount recalled
- 1,225 total USMs
Where it was sold
Why it was recalled
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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