FDA Medical Device Recalls (openFDA)
International Technidyne Corp.: International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
- Recall number
- Z-1237-2008
- Recalling firm
- International Technidyne Corp.
- Product
- International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
- Status
- Terminated
- Initiated
- 2008-02-13
- Posted
- 2008-08-06
- Terminated
- 2009-07-24
- Reason
- Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
- Root cause
- Process design
- Action
- ITC sent Urgent - Medical Device Field Recall - ITC No. 08-001 letters dated 2/08/2008 to hospitals and/or medical facilities identified as having affected instruments. The letter instructed users not to use the instrument if the diagnostic mode is enabled. ITC will reset affected devices and return them to the customers.
- Quantity
- 7 units
- Distribution
- Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
- Lot, serial or model codes
- Serial Numbers: 1073, 1085, 1197, 1245, 1321, 1383, 1162. Catalog Numbers/Code: AVON1000-110 and AVOX-1000-220. Note:w The AVOXimeter 1000 was discontinued in 1996 by the company which which ITC acquired the product line from (AVOX Systems in Texas. Today, only service is offered on this mode.
- 510(k) numbers
- K922075
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1000526865
- Firm city
- Edison
- Firm state
- NJ
- 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