Terminated

The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N''

FDA Recall Z-0568-04 · Posted 2004-07-20

Recalling FirmCardiocommand Inc.

Recall StatusTerminated

Product CodeLPA

Date Initiated2003-10-27

Date Terminated2011-12-21

Product Quantity307

Reason for Recall

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

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.