Intuitive Surgical Recalls da Vinci Surgeon Side Console Touchpads
Intuitive Surgical is recalling 542 da Vinci Si and Xi Surgeon Side Console touchpads due to a Class II defect. The recall covers units distributed in the US and 33 other countries.
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 is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is voluntarily recalling 542 units of the da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC) Touchpad, model number 187505-04. The recall includes 351 SCC Touchpads and 191 PSC touchpads. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments and can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
The FDA has classified this recall as Class II, indicating 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. The recall was initiated by the firm on February 16, 2016, and was terminated on September 21, 2016.
The affected units were distributed in the United States and 33 other countries, including Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
Distribution
Distribution scope not specified by the agency.
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