1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercia

FDA device recall Z-2631-2011 · posted 2011-06-23 · Terminated

Recall details

Recalling firm

St Jude Medical

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 but

Action taken

The 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.

Root cause

Other

Status

Terminated

Quantity affected

10

Distribution

International distribution only: Canada and Japan.

Date initiated

2011-05-09

Date posted

2011-06-23

Date terminated

2012-04-03

Location

Saint Paul, MN