Intuitive Surgical Recalls da Vinci Xi Patient Side Carts Due to Sensor Failure
Intuitive Surgical is recalling 75 da Vinci Xi Patient Side Carts because a motor sensor failure can occur after a mid-procedure restart.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device where a motor sensor failure could lead to injury during surgery, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 75 units of the ASSEMBLY, PATIENT SIDE CART, PS4000, which is used with the da Vinci Xi Surgical System. The recall is due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
The affected devices were distributed worldwide, including in the United States, Belgium, Germany, China (Hong Kong), India, Israel, Italy, and the United Kingdom. The specific part number is 380652, and the recall includes 75 specific serial numbers listed in the agency's records.
Hospitals and healthcare facilities should contact Intuitive Surgical, Inc. for instructions on how to handle the affected devices. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 75
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 (1)
- PATIENT SIDE CART
Distribution
Distributed nationwide across the United States.
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