da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reported: February 11, 2015 Initiated: January 15, 2015 #Z-1048-2015
Product Description
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1,034
- Distribution
- Nationwide Distribution
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: 1,034.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1048-2015.
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