EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a
FDA device recall Z-0914-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- EP Medsystems
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOQ
- Quantity affected
- 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, Ita
- Date initiated
- 2006-04-04
- Date posted
- 2006-05-31
- Date terminated
- 2007-04-24
- Location
- West Berlin, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EP-4 CLINICAL STIMUTATOR (K041442) | Ep Medsystems | 2004-09-14 |
| EP-4 CLINICAL STIMULATOR (K040207) | Ep Medsystems | 2004-02-27 |