Intuitive Surgical Recalls da Vinci Xi Systems Due to Software Anomaly
Intuitive Surgical is recalling 677 da Vinci Xi Surgical Systems due to a software anomaly that may cause unexpected movement.
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 software defect could cause unexpected movement during surgery, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 677 da Vinci Xi Surgical Systems (Model IS4000) equipped with P5 software. The recall involves systems manufactured with or upgraded to P5 software.
The recall was initiated because Intuitive Surgical identified a software anomaly in the P5 software. This anomaly can result in unexpected master movement and potential instrument tip movement under certain circumstances.
The affected devices were distributed in the United States and 29 other countries, including Australia, Austria, Belgium, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical…
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 677
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)
- All systems manufactured with or upgraded to P5 software.
Distribution
Distributed in 1 state:
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