Z-0350-06

IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable

Name: Z-0350-06 IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable
Creator: Merit Medical Systems, Inc
Published: 2005-11-07
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2005-11-07 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable on 2005-11-07. The reason FDA records is "Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0350-06
Status: Terminated
Initiated: 2005-11-07
Posted: 2006-01-06
Terminated: 2006-03-14
Recalling firm: Merit Medical Systems, Inc.
Product: IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
FDA root cause: Other
Action: Sale representatives and consignees were notified by letter.
Quantity in commerce: 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, France, Germany, Israel, Japan, Mexico, Netherland, New Zealand, UK and Wales.
Product codes and lots: Catalog Number IN1615. Serial Numbers: T2370-0025, T2370-0035, T2370-0037, T2370-0046, T2370-0053, T2370-0057, T2370-0058, T2370-0068, T2370-0069, T2370-0071, T2370-0072, T2370-0073, T2370-0075, T2370-0076, T2370-0077, T2370-0078, T2482-0013, T2482--0020, T2482-0030, T2482-0032, T2482-0035, T2482-0041, T2482-0043, T2482-0065.

Product code MAV

K993341Class IIIntellisystem II Color MonitorMerit Medical Systems, Inc. / cleared 1999-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)