Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults
Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical robot that can cause loss of functionality during surgery, meeting the criteria for a Severe rating.
Plain-English summary
Intuitive Surgical, Inc. is recalling 74 User System Modules (USMs) of the da Vinci Xi Surgical System (Model IS4000). The recall is due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and 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. They were also distributed internationally to Australia, France, Germany, and Japan.
Healthcare facilities should contact Intuitive Surgical for instructions on how to address the affected units. The recall is classified as Class II by the FDA.
The recalled product
- Product
- da Vinci Xi Surgical System
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 74
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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