As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY, Special Storage Condition, Specify: Do not use open or damaged packages, Special Storage Condition, Specify: Store in a cool dry place. Labeling does not contain MRI Safety Information, Cardiac mapping catheter, percutaneous, single-use. Instructions for Downloading Viewers and Players, Class 2 Device Recall PENTARAY NAV Catheter and PENTARAY NAV ECO Catheter. 47 Biosense Webster jobs available on Indeed.com. As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. The customers were instructed to read the "Description of the Problem" section carefully; immediately identify and set aside all affected lots; maintain a copy of this letter with the affected PentaRay NAV Catheters until all units are returned to Biosense Webster; complete and return the Voluntary Field Removal Certification form via mail to: Biosense Webster, Inc., Attn: Field Action Coordinator, 15715 Arrow Highway, Irwindale, CA 91706, Fax to: 909-839-8514 or email to: rkazmi@its.jnj.com; arrange for return of all affected units you may have in your inventory; pass on this notice to anyone in your facility that needs to be informed, and if any of the affected product have been forwarded to another facility, contact that facility and arrange for the return. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. Reproduced with Permission from the GMDN Agency. $999.00 box of 1 - Biosense Webster # D128208 - Biosense Webster Carto PentaRay Eco High Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. Customers with questions related to the Acknowledgement form and its return, are instructed to contact the Field Action Coordinator at (909) 839-8468. This website also uses Open Source Software (OSS) provided by LiveChat to provide customer support. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. This is a single-use device. Apply to Cardiology Physician, Biostatistician, Technician and more! Customers with questions related to the information provided in the customer notification, are instructed to contact their Biosense Webster sales representative or call (866)473-7823, Monday through Friday from 7am to 8pm EST. Biosense Webster, Inc. is a global leader in the science of diagnosing and treating heart rhythm disorders. The letter provides important information about the affected products and instructions on how the customers can return the affected products to Biosense Webster. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. Sign in to add this product to your favorites! 510(K)s with Product Code = MTD and Original Applicant = BIOSENSE WEBSTER, INC. * PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. We use cookies for Google Analytics and session tracking for your secure shopping experience. The letter describes the product, the problems identified and the actions to be taken. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Catheter,intracardiac mapping,high-density array, Code of Federal Regulations (CFR) Title 21 §7.55. D128205, D128207, D128208, D128210, D128211). In Stock! Brand Name: PENTARAY NAV Version or Model: D128208 Commercial Distribution Status: In Commercial Distribution Catalog Number: D128208 Company Name: BIOSENSE WEBSTER INC. GMDN Names and Definitions: © Copyright GMDN Agency 2015. As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. Instructions for Downloading Viewers and Players. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies. Enjoy higher signal resolution using this navigational diagnostic catheter with five soft, flexible branches for better coverage. The firm, Biosense Webster, sent an "URGENT FIELD SAFETY NOTICE MEDICAL DEVICE-VOLUNTARY FIELD RECALL (REMOVAL)" letter dated February 18, 2014 to all customers who purchased the PentaRay Nav Catheter.
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