Intuitive Surgical Recalls da Vinci Si Vision Side Carts Due to Wheel Loosening
Intuitive Surgical is voluntarily correcting 202 da Vinci Si Vision Side Carts where caster wheel bolts may unthread, causing wheels to loosen.
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 involves a medical device with a mechanical defect (loosening wheels) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is initiating a voluntary correction for 202 units of the IS3000 Vision Side Cart (VSC) used with the da Vinci Si Surgical System. The affected carts, identified by product number 371683-05 and model number VS3000, feature threaded-in caster wheels.
The recall is due to a defect where the caster wheel bolts can gradually unthread, resulting in the wheels loosening. The affected units were distributed worldwide, including the United States and 13 other countries.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Intuitive Surgical is managing this voluntary correction to address the mechanical issue.
The recalled product
- Product
- IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to…
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 202
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 (20)
- Product number 371683-05/Model Number VS3000 Serial numbers - USA: SH0018
- SH0057
- SH0097
- SH0132
- SH0165
- SH0235
- SH0019
- SH0058
- SH0098
- SH0133
- SH0167
- SH0248
- SH0021
- SH0059
- SH0099
- SH0134
- SH0168
- USG015
- SH0024
- SH0060
Distribution
Distributed nationwide across the United States.
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