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U.S. Department of Health and Human Services

Class 2 Device Recall 1500T14 Cardiac Ablation System Remote Control

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 Class 2 Device Recall 1500T14 Cardiac Ablation System Remote Controlsee related information
Date Initiated by FirmMay 09, 2011
Date PostedJune 23, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall NumberZ-2632-2011
Recall Event ID 58859
Product1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable. It has a duplicate front panel controls and displays as of the generator's front panel, with the addition of an optical encoder knob which is used to select and changes the parameters.
Code Information Serial Number: 13615332, 13615330, 13615328, 13615331
Recalling Firm/
Manufacturer		 St Jude Medical
One St Jude Medical Dr
Saint Paul MN 55117
Manufacturer Reason
for Recall		The recall was initiated because St. Jude Medical has confirmed its T14 and T12 RF Generator may malfunction upon encountering an unexpected electric current (e.g. static electricity). The resulting 'malfunction results in a failure of the generator to respond to key presses properly, and may cause unexpected energy delivery or inability to discontinue energy delivery with the start/ stop butt
FDA Determined
Cause 2		Other
ActionThe firm, St. Jude Medical (SJM), sent a "Product Correction" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit. If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.
Quantity in Commerce4
DistributionInternational distribution only: Canada and Japan.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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