Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.
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 high-risk medical device where a hazard (increased metallic particulates) is identified, but the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling the user manuals, instruments, and accessories for the da Vinci S Surgical System (models IS1200, IS2000, and IS3000). The recall involves 248 units across all models and languages.
The recall was initiated because the company found that using instruments other than the Cardiac Probe Grasper, such as the Large Needle Driver Instrument, to manipulate ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from contact with the probes.
The affected products were distributed worldwide, including in the United States and numerous other countries such as Australia, Canada, and the United Kingdom. The source text does not specify the actions consumers or healthcare providers should take in response to this recall.
The recalled product
- Product
- da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 248
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 (3)
- Model 550675
- IS1200/IS2000/IS3000 - User Manual
- Instrument & Accessory - all languages.
Distribution
Distributed nationwide across the United States.
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.
See all 2 products in this recall →Related recalls
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Same hazard · metallic particulates
See all →- HighIntuitive Surgical Recalls da Vinci S Surgical System User Manuals
FDA (Devices) · 2016-04-20
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