Da Vinci 5 Surgical System Console Recalled Due to Software Error
Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.
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 product is a surgical system where a loss of user interface content during surgery represents a high risk of harm, though no injuries were reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 (Model/Catalog Number: 380730) used for minimally invasive surgery.
A software error following the release of software version P1.2.1 can result in the loss of user interface content on an external monitor or tower monitor.
This recall affects 12 units distributed in LA, MA, NY, PA, TX, and VA. Users should follow manufacturer instructions regarding the software error.
The recalled product
- Product
- Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 12
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 (1)
- UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Distribution
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