INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrum
FDA device recall Z-1949-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
- Action taken
- Intuitive Surgical sent an Urgent Medical Device Notification letter on June 16 , 2015 to all affected consignees. Consignees were instructed to take the following actions: 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures. 2. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 3. Please retain a copy of this notice with your system. 4. Refer to the da Vinci Xi System User Manual for more information on draping the system. Consignees with questions or needing spport should contact their Clinical Sales Representative or contact Intuitive Surgical Sustomer Service at the numbers listed below: Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) .
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 310
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qat
- Date initiated
- 2015-06-16
- Date posted
- 2015-07-01
- Date terminated
- 2015-10-05
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |