FDA Medical Device Recalls (openFDA)
Mallinckrodt Inc: OptiVantage DH Power Injection System.
- Recall number
- Z-0288-2007
- Recalling firm
- Mallinckrodt Inc
- Product
- OptiVantage DH Power Injection System.
- Status
- Terminated
- Initiated
- 2006-11-07
- Posted
- 2006-12-16
- Terminated
- 2007-07-21
- Reason
- The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
- Root cause
- Other
- Action
- The recalling firm sent a letter dated 11/7/2006 to all consignees.
- Quantity
- 1348 devices.
- Distribution
- Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.
- Lot, serial or model codes
- All codes.
- 510(k) numbers
- ["K042744"]
- PMA numbers
- not on file
- Product code
- CXT
- Firm FEI
- 1518293
- Firm city
- Cincinnati
- Firm state
- OH
- 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