FDA Medical Device Recalls (openFDA)
Medrad Inc: Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
- Recall number
- Z-0154-06
- Recalling firm
- Medrad Inc
- Product
- Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
- Status
- Terminated
- Initiated
- 2005-10-10
- Posted
- 2005-11-16
- Terminated
- 2007-08-15
- Reason
- the heat maintainer, an accessory, may overheat and deform the disposable syringe
- Root cause
- Other
- Action
- The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.
- Quantity
- 4362 units
- Distribution
- The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- ["K023183","K033881"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- 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