Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration
Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical 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 involves a medical device with a mechanical defect that could lead to system faults or physical damage (cracks/vibration) during use. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling two units of the Patient Side Cart assembly, 4-arm, for use with the da Vinci Surgical System IS 4000. The recall is limited to lot 380652-20. These devices were distributed to medical facilities in Texas and Florida.
The recall was initiated because the torque wrenches used to tighten certain Patient Side Cart (PSC) bolts were out of calibration. This error could lead to over- or under-tightening of the bolts. Such conditions may result in system faults, mechanical sounds (such as scraping, squeaking, or rattling), cracks, or vibration in the system.
No specific instructions for consumers are provided in the source text, as the devices are located in medical facilities. The source does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any…
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 2
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)
- lot 380652-20
Distribution
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