FDAFDA · Food and drugs·Recall number Z-1718-2014
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.
Published June 11, 2014 · Recall initiated: May 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Medical facilities in TX and FL
- Lot
- lot 380652-20
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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