The Recall Desk
HighFDA (Devices)·Z-1376-2016·Announced 2016-04-20

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.

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 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 endosco
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robotics
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

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · metallic particulates

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