Intuitive Surgical Recalls da Vinci Vision System Cart Components
Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a software/control board error causing false alerts rather than a direct physical hazard to patients.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000, along with Y1903 Illuminators and Y1902 Replacement Lamp Modules. The recall involves 161 standalone units, 240 units with Vision Starter Kits, and 283 units with IS3000 Vision Carts.
The recall was initiated because the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board. This incompatibility can lead to an erroneous red Preventive Maintenance Message appearing on monitors. The affected products were distributed worldwide, including in the United States and various international markets.
Hospitals and surgical centers should check their inventory for the specific serial numbers listed in the official recall notice. If the affected components are present, they should stop using them and contact Intuitive Surgical for instructions on replacement or repair.
The recalled product
- Product
- da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD…
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Hazard
Distribution
Distributed nationwide across the United States.
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