Atlas FDA

Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile

FDA device recall Z-0124-06 · posted 2005-11-03 · Terminated

Recall details

Recalling firm
Remington Medical Inc.
Reason for recall
The vector selector has an electrical design flaw which prevents RV pacing.
Action taken
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
Status
Terminated
Product code
DTA
Quantity affected
600 units
Distribution
MN
Date initiated
2005-08-31
Date posted
2005-11-03
Date terminated
2007-05-09
Location
Alpharetta, GA

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Related 510(k) clearances

RecordFirmDate
ADAPTER CABLE (K050884)Remington Medical, Inc.2005-05-19