Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.
FDA Recall Z-0124-06 · Posted 2005-11-03
Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeDTA
Date Initiated2005-08-31
Date Terminated2007-05-09
Product Quantity600 units
Reason for Recall
The vector selector has an electrical design flaw which prevents RV pacing.
Firm Action
Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005.
Root Cause
Other
Distribution Pattern
MN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.