da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate co
FDA device recall Z-1048-2015 · posted 2015-02-03 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1,034
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-01-15
- Date posted
- 2015-02-03
- Date terminated
- 2015-03-03
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS (K123463) | Intuitive Surgical, Inc. | 2012-12-03 |