Device Recall da Vinci Si Surgical System 의 리콜

Recall

70181

Class 2

Z-1048-2015

2015-01-15

2015-02-03

Terminated

United States

2015-03-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132453

The wall chart has been updated because it was noted that wall chart (pn 551524-03 rev a) was inconsistent with the user manual adendum (pn 550986-07_b) with regards to neceassary sterilization dry time.

Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on the updated instructions for use. A Clinical Sales Representative or Intuitive Surgical Customer Service at 1-800-876-1310, should be contacted if further information or support is needed concerning the recall notification.