Intuitive Recalls 17 da Vinci SP Surgical Systems Due to Software Anomaly
Intuitive Surgical is recalling 17 da Vinci SP surgical systems because a software anomaly may cause mechanical vibration of instrument tips and the endoscope under rare conditions.
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 involves a medical device with a potential for mechanical vibration during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 17 units of the da Vinci SP surgical system. The recall is due to a software anomaly that may trigger mechanical vibration of the instrument tips and the endoscope. This issue has the potential to occur only under extremely rare specific conditions: the user is activating Adjust Mode, the instrument Arm is near its vertical position limit, and the user is applying sustained force against the hand control haptic feedback.
The affected units are distributed in the United States in Ohio, Pennsylvania, New York, Minnesota, Tennessee, Texas, Oregon, Illinois, Maryland, New Jersey, and Alabama, as well as in South Korea. The specific serial numbers for the recalled units are SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, and SP0030.
The source text does not specify the corrective action or instructions for consumers or healthcare providers. Users should contact Intuitive Surgical for further information regarding the recall and any necessary remediation.
The recalled product
- Product
- da Vinci SP surgical system
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Hazard
- Affected units
- 17
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 (17)
- Serial Numbers: SP0022
- SP0031
- SP0023
- SP0032
- SP0024
- SP0034
- SP0025
- SP0035
- SP0026
- SP0036
- SP0027
- SP0037
- SP0028
- SP0038
- SP0029
- SP0039
- SP0030
Distribution
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