Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. Th
FDA device recall Z-1226-2015 · posted 2015-02-27 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
- Action taken
- Urgent Medical Device Recall letters were sent on February 16, 2015
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 706 units
- Distribution
- US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom
- Date initiated
- 2015-02-16
- Date posted
- 2015-02-27
- Date terminated
- 2015-07-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER (K080291) | Intuitive Surgical, Inc. | 2008-03-19 |
| INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 (K060391) | Intuitive Surgical, Inc. | 2006-04-10 |