EP Medsystems 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
EP Medsystems
Lot Codes / Batch Numbers
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.
Products Sold
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.
EP Medsystems is recalling EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen port due to Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the devic. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026