IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
FDA device recall Z-0350-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
- Action taken
- Sale representatives and consignees were notified by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAV
- Quantity affected
- 24 units
- Distribution
- Device was distributed in the US, Canada and worlwide. US distribution includes: AL, IN, MD, MS, NJ, OH, OR, PA, TN, TX, and WA. Foreign consignees include: Argentinal, Australia, Belgium, Brazil, Fra
- Date initiated
- 2005-11-07
- Date posted
- 2006-01-06
- Date terminated
- 2006-03-14
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLISYSTEM II COLOR MONITOR (K993341) | Merit Medical Systems, Inc. | 1999-10-25 |