FDAClass IIJune 11, 2014

Patient Side Cart assembly recall

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…

Why was Patient Side Cart assembly recalled?

Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot 380652-20

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…
Recalling firm
Intuitive Surgical, Inc.
Quantity
2
Distribution
Medical facilities in TX and FL
Recall date
June 11, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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