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U.S. Department of Health and Human Services

Class 2 Device Recall Assembly, Patient Side Cart

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  Class 2 Device Recall Assembly, Patient Side Cart see related information
Date Initiated by Firm May 09, 2014
Date Posted June 04, 2014
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-1718-2014
Recall Event ID 68358
510(K)Number K131861  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
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 arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
Code Information lot 380652-20
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Intuitive sent an Urgent Medical Device Correction letter dated May 13, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. All personnel who use the device should be notified of the issue and the acknowledgement form completed and returned. Intuitive reps will visit each affect sites to install a replacement PSC and ensure that it is properly integrated with the Da Vinci. For questions contact Intuitive Surgical at 800-876-1310 Option 3 (Monday - Friday 6 am to 5 pm PST).
Quantity in Commerce 2
Distribution Medical facilities in TX and FL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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