Intuitive da Vinci SP Surgical System Cannula Mount Button Recall
Intuitive Surgical is recalling five da Vinci SP surgical systems because the cannula mount button may be damaged if released abruptly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential mechanical defect (button damage) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling five units of the da Vinci SP surgical system (Model SP 1098) in the United States. The recall involves specific systems identified by the codes SP0022, SP0023, SP0024, SP0025, and SP0026.
The recall was initiated because the cannula mount button on the Patient Cart may be damaged if the user releases the button abruptly. The da Vinci SP system consists of a Surgeon Console, a Vision Cart, and a Patient Cart, with the Patient Cart serving as the operative component for positioning the surgical port and manipulating instruments.
The affected systems were distributed in Minnesota, New York, Ohio, and Pennsylvania. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- The da Vinci SP surgical system 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 SP system and its primary function is to support the positioning of the surgical port (c
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Hazard
- Affected units
- 5
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 (4)
- The Affected Systems are : SP0022
- SP0023
- SP0024
- SP0025 and SP0026.
Distribution
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