FDA Medical Device Recalls (openFDA)
Datex-Ohmeda Inc: Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
- Recall number
- Z-0969-04
- Recalling firm
- Datex-Ohmeda Inc
- Product
- Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
- Status
- Terminated
- Initiated
- 2004-04-16
- Posted
- 2004-07-20
- Terminated
- 2005-11-14
- Reason
- Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
- Root cause
- Other
- Action
- Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
- Quantity
- 10 units
- Distribution
- The affected units were distributed nationwide in the United States and worldwide.
- Lot, serial or model codes
- Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124
- 510(k) numbers
- K993410
- PMA numbers
- not on file
- Product code
- CBN
- Firm FEI
- 2183066
- Firm city
- Madison
- Firm state
- WI
- 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