FDA Medical Device Recalls (openFDA)
International Technidyne Corp.: International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
- Recall number
- Z-1239-2008
- Recalling firm
- International Technidyne Corp.
- Product
- International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
- 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
- 61 US, 2 International
- 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
- 41018 41068 41096 41124 41146 41175 41280 41323 41325 41384 41423 41430 41453 41480 41484 41489 41505 41506 41532 41533 41555 41560 41566 41570 41571 41572 41573 41574 41575 41576 41577 41578 41578 41579 41580 41581 41582 41582 41583 41584 41585 41586 41588 41589 41592 41593 41594 41595 41601 41605 41607 41608 41609 41610 41611 41612 41613 41614 41615 41616 41617 41618 41619 41620 41632 41633 41634 41635 41636 41637 41638 41639 Q-1034 Catalog/Code Numbers: AVOX4000-110 and AVOX4000-220.
- 510(k) numbers
- ["K951485"]
- PMA numbers
- not on file
- Product code
- JKS
- 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