Z-0914-06

EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC...

Name: Z-0914-06 EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC...
Creator: EP Medsystems
Published: 2006-04-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-04-04 / Terminated

FDA source

EP Medsystems began a recall of EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator... on 2006-04-04. The reason FDA records is "Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0914-06
Status: Terminated
Initiated: 2006-04-04
Posted: 2006-05-31
Terminated: 2007-04-24
Recalling firm: Abbott Medical
Product: EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.
Product code: JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Reason for recall: Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system
FDA root cause: Other
Action: The firm initiated the recall on April 4, 2006 through a notification letter sent to the electrophysiology lab managers at the healthcare institutions and two domestic distributors to which the device has been distributed. The firm used a traceable courier service to deliver notification of the recall.
Quantity in commerce: 187 units
Distribution: Product was shipped to hospitals/users throughout the US. The firm has a Veterans Affair contract number V797P-4650A. Also the firm has shipped the devices to Germany, United Kingdom, Netherlands, Italy, Japan, France, Saudi Arabia, Hong Kong, Syria, Malaysia, Sweden, Armenia, Australia, Canada, Iceland, S. Africa, and Taiwan.
Product codes and lots: Model number: EP-4-02 and EP-4-04. EP40312-001 through 010; EP40403-001 through 014; EP40406-001 through 042; EP40408-001 through 039; EP40410-001 through 040; EP40411-001 thourgh 040; EP40504-001 through 040; EP40506-001 through 040; EP40508-001 through 020; EP40510-001 through 020; EP40511-001 through 040.

Product code JOQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)