CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This produc
FDA device recall Z-0884-2011 · posted 2011-01-07 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
- Action taken
- Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DSA
- Quantity affected
- 1692
- Distribution
- Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countr
- Date initiated
- 2010-10-05
- Date posted
- 2011-01-07
- Date terminated
- 2012-05-07
- Location
- Irwindale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES (K090017) | Biosense Webster, Inc. | 2009-10-13 |