Reported Mar 22, 2023 · Ongoing
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: 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?
4 of 4 products
| Model / number | Product as published |
|---|---|
380620 | with instrument arms, used as part of the da Vinci X Surgical System |
IS4200 | Patient Side Cart |
380652 | with instrument arms, used as part of the da Vinci Xi Surgical System |
IS4000 | — |
- Lot codes and dates
- System REFSerial Numbers/Cart
- REF/UDI-DI/Arm Serial Numbers
IS4200: SL0379SL0069/ 380620/ 00886874115404/ 668080575093
- IS4000
SK1402SK0991SK2332SK0744SK0110SK0753/380652 / 00886874110720/ 372054663693557322547953425439409962
- Amount recalled
- 9
Where it was sold
Why it was recalled
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
This product could cause temporary or reversible health problems — stop using it.
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