Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Par
FDA device recall Z-0258-2008 · posted 2008-01-24 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
- Action taken
- On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1,136 units
- Distribution
- Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, A
- Date initiated
- 2007-04-13
- Date posted
- 2008-01-24
- Date terminated
- 2008-08-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 (K061260) | Intuitive Surgical, Inc. | 2006-05-18 |