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U.S. Department of Health and Human Services

Class 2 Device Recall IS4000 da Vinci Xi Endoscope accessory

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 Class 2 Device Recall IS4000 da Vinci Xi Endoscope accessorysee related information
Date Initiated by FirmJune 11, 2014
Date PostedJune 25, 2014
Recall Status1 Terminated 3 on July 02, 2014
Recall NumberZ-1871-2014
Recall Event ID 68531
Product Classification System,surgical,computer controlled instrument - Product Code NAY
ProductIS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Code Information 470026-18
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information ContactMark Johnson
408-523-2100
Manufacturer Reason
for Recall		In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
FDA Determined
Cause 2		Device Design
ActionMedical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your records. Intuitive representatives will schedule a site visit to provide the re-calibrated endoscope, update the software and ensure that it is properly integrated with the da Vinci Xi Surgical System. Questions or concerns may be directed to Intuitive Customer Service at 800-876-1310.
Quantity in Commerce19 units
DistributionDistributed in the states of FL, TX, and NY.
Total Product Life CycleTPLC 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.
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