Recall Z-1422-2009 ยท JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
St. Jude Medical
EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.
| Date | Jun 12, 2009 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 694 total (US, Canada, and OUS) |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |