Surgical robots recalled over a software error hiding failed arm diagnostics
Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.
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: Scored 3 under the risk-of-harm criterion: the firm states failing arms remained in clinical use with ball screws that are a precursor to fatigue failure or fracture, and no injuries are reported.
Plain-English summary
The da Vinci X, Xi Surgical System and da Vinci 5 Surgical System, model/catalog numbers IS4000, IS4200 and IS5000, are being recalled by Intuitive Surgical, Inc. The record states each system consists of three main components: the Surgeon Console, the Vision Cart and the Patient Cart, with the Patient Cart the operative component.
The reason given in the enforcement record is a software implementation error that allowed instrument arms failing an important diagnostic test to remain in clinical use. The record states this test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned, which is a precursor to potential ball screw fatigue failure or fracture.
The record lists 219 units under UDI 00886874114216 and FDA medical device listing number D531324. Distribution was to a wide range of US states and to other countries listed in the enforcement record. The FDA has classified the action as Class II.
An arm kept in clinical use despite failing its diagnostic test may carry a component heading toward fatigue failure. The enforcement record reports no injuries. Facilities should follow Intuitive Surgical's instructions.
The recalled product
- Product
- Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 219
Distribution
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