Intuitive Surgical Recalls da Vinci X Universal Surgical Manipulators
Intuitive Surgical is recalling 270 Universal Surgical Manipulators for da Vinci X systems due to high friction causing arm movement issues.
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 is classified as FDA Class II, and the hazard involves mechanical failure during surgery (resistance, hesitation, jerking) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical Inc is recalling 270 Universal Surgical Manipulators (USMs) used in the da Vinci X Surgical System (IS4200). The recall affects 100 unique systems, with four USMs per system. The devices are distributed worldwide, including in the United States and various international locations.
The recall is due to high friction points in the USMs, which can result in increased arm movement. This may cause feelings of resistance, hesitation, and jerking during surgical procedures. The affected serial numbers are SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, and SL0357.
Healthcare facilities and users should contact Intuitive Surgical Inc for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its…
- Manufacturer
- Intuitive Surgical Inc
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 (11)
- UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085
- SL0315
- SL0317
- SL0324
- SL0338
- SL0350
- SL0351
- SL0353
- SL0354
- SL0357
- SL0369
Distribution
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.
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