FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
- Recall number
- Z-0350-06
- 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.
- Status
- Terminated
- Initiated
- 2005-11-07
- Posted
- 2006-01-06
- Terminated
- 2006-03-14
- Reason
- Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
- Root cause
- Other
- Action
- Sale representatives and consignees were notified by letter.
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K993341"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28