The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and

FDA device recall Z-0568-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Cardiocommand Inc.

Reason for recall

The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.

Action taken

The firm notified all user accounts and distributors by mailing a recall notifiation letter via certified first class mail on 10/31/2003 with a serial number list, photo of the device and a 'RECALL INFORMATION RETURN SHEET' for response. A second recall letter was sent out on January 15, 2004 via certified mail to all non responding accounts. The firms were asked to return recalled units, or identify the address of accounts they were transferred to and to notify these accounts.

Root cause

Other

Status

Terminated

Product code

LPA

Quantity affected

307

Distribution

The devices under recall are at 142 domestic hospitals nationwide and to eight distributors in Canada, Hong Kong, the Netherlands, LA, HI, KY, AR and FL.

Date initiated

2003-10-27

Date posted

2004-07-20

Date terminated

2011-12-21

Location

Tampa, FL