EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 No
FDA device recall Z-1422-2009 · posted 2009-06-12 · Terminated
Recall details
- Recalling firm
- St. Jude Medical
- Reason for recall
- Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.
- Action taken
- All foreign customers were sent Urgent Product Safety Information letters on March 23, 2009. Letters described units affected, the reason for action, and the actions to take to eliminate risk. It is recommended that the information in the letter be circulated to all users, risk managers and the biomedical engineering department responsible for maintaining and inspecting electrical equipment located within their institution. The letter also stated that a SJM representative will be in touch to perform the EP-4 Stimulator fuse modification. Customers are to complete and return the attachment.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JOQ
- Quantity affected
- 694 total (US, Canada, and OUS)
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-03-23
- Date posted
- 2009-06-12
- Date terminated
- 2010-01-20
- Location
- West Berlin, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EP-4 CLINICAL STIMULATOR (K040207) | Ep Medsystems | 2004-02-27 |
| EP MEDSYSTEMS, EP-WORKMATE (K994011) | Ep Medsystems, Inc. | 2000-03-23 |