Intuitive Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1718-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
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 arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
Class II
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.
lot 380652-20
Medical facilities in TX and FL
Voluntary: Firm initiated