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Terminated

IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable

FDA Recall Z-0349-06 · Posted 2006-01-06

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeMAV
Date Initiated2005-11-07
Date Terminated2006-03-14
Product Quantity35 units

Reason for Recall

Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

Firm Action

Sale representatives and consignees were notified by letter.

Root Cause

Other

Distribution Pattern

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, France, Germany, Israel, Japan, Mexico, Netherland, New Zealand, UK and Wales.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993341INTELLISYSTEM II COLOR MONITORMerit Medical Systems, Inc. · 1999-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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