EM2M NC AEM Monitor, (NON-COM)
FDA device recall Z-1052-03 · posted 2003-07-24 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- Action taken
- Accounts were visited by sales representatives beginning 6/23/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2 units
- Distribution
- CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
- Date initiated
- 2003-06-23
- Date posted
- 2003-07-24
- Date terminated
- 2003-11-06
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIVE ELECTRODE MONITORING SYSTEM (K000480) | Electroscope, Inc. | 2000-05-02 |