Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue
Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a surgical device that could compromise safety during procedures, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 10 units of the da Vinci Xi Surgical System (IS4000). The recall is due to a defect where the patient side carts (PSC) were shipped with potentially under-torqued brake screws in a section of the system arms.
The da Vinci Xi Surgical System is designed to assist surgeons in controlling instruments during endoscopic surgery. The affected units were distributed worldwide, including in the United States (Texas, New York, Florida, Illinois, and Ohio) and in France, Ireland, Japan, and Taiwan.
Healthcare facilities should contact Intuitive Surgical for instructions on how to address the defect. The specific serial numbers for the affected units are SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, and SK1190.
The recalled product
- Product
- da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal m
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Serial Numbers: SK0822
- SK1154
- SK1001
- SK1170
- SK1040
- SK1176
- SK1082
- SK1180
- SK1146
- SK1190
Distribution
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