Intuitive Surgical Recalls da Vinci Si Surgical Systems Due to Mounting Risk
Intuitive Surgical is recalling 1,090 da Vinci Si Surgical Systems because improper restraints during transport could cause the monitor to become loose from its mount.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,090 da Vinci Si Surgical System IS3000 consoles. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. The recall covers model numbers 380610-04 through 38-610-14.
The recall was initiated because improper restraints during transportation of the da Vinci system could cause the High Resolution Stereoscopic Viewer (HRSV) Monitor to become loose from its mount. This defect presents a potential safety risk during the movement of the equipment.
The affected consoles were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations such as Australia, Canada, China, France, Germany, India, and the United Kingdom. Users of these systems should contact Intuitive Surgical for further instructions on how to address the restraint issue.
The recalled product
- Product
- da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,090
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 numbers 380610-04 through 38-610-14.
Distribution
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