Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault
Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.
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 is classified as FDA Class II. The hazard involves a loss of functionality during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 74 da Vinci X Surgical Systems (Model IS4200) due to a manufacturing variation in the arm. This defect can result in a persistent recoverable fault error (error 23087) and a loss of arm functionality prior to or during surgery.
The affected units were distributed in the United States to California, Maryland, New York, Virginia, Illinois, Michigan, Delaware, Texas, Florida, New Jersey, Massachusetts, Kentucky, and Ohio. The company also distributed units to Australia, France, Germany, and Japan.
Healthcare facilities should contact Intuitive Surgical for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- da Vinci X Surgical System
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 74
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)
- Model: IS4200 UDI: 00886874114216 Device Listing: D295931
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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