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EP-4™
ST. JUDE MEDICAL, INC. · Model Cardiac Stimulator · UDI-DI 05414734208741
JOQ
Prescription
1
510(k) clearances
149
Adverse events (2 deaths)
3
Recalls
7
Facilities
Description
Cardiac Stimulator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-03-23 | St. Jude Medical | 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 t |
| 2006-04-04 | EP Medsystems | 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 |
| 2005-01-13 | Fischer Imaging Corporation | Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.