FDA Medical Device Recalls (openFDA)
Sechrist Industries Inc: Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
- Recall number
- Z-1032-04
- Recalling firm
- Sechrist Industries Inc
- Product
- Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
- Status
- Terminated
- Initiated
- 2004-05-20
- Posted
- 2004-07-20
- Terminated
- 2006-03-14
- Reason
- Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
- Root cause
- Other
- Action
- Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer.
- Quantity
- 240
- Distribution
- Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.
- Lot, serial or model codes
- Restricted to those ventilators with production serial numbers beginning with a ''00'' prefix.
- 510(k) numbers
- ["K811141","K833982","K920121"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2020676
- Firm city
- Anaheim
- Firm state
- CA
- 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