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U.S. Department of Health and Human Services

Class 2 Device Recall EP4 Computerized Stimulator

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 Class 2 Device Recall EP4 Computerized Stimulatorsee related information
Date Initiated by FirmApril 04, 2006
Date PostedMay 31, 2006
Recall Status1 Terminated 3 on April 24, 2007
Recall NumberZ-0914-06
Recall Event ID 35206
510(K)NumberK040207 K041442 
Product Classification Stimulator - Product Code JOQ
ProductEP-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.
Code Information 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.
Recalling Firm/
Manufacturer		 EP Medsystems
575 Route 73 North, Bldg D
Cooper Run Executive Park
West Berlin NJ 08091
For Additional Information ContactTom Maguire
856-753-8533 Ext. 219
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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 Commerce187 units
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JOQ
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