FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
- Recall number
- Z-1676-2011
- Recalling firm
- AGFA Corp.
- Product
- IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
- Status
- Terminated
- Initiated
- 2011-02-10
- Posted
- 2011-03-16
- Terminated
- 2011-09-15
- Reason
- A discrepancy in the validation testing which resulted in the product not performing as intended.
- Root cause
- Device Design
- Action
- AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.
- Quantity
- One
- Distribution
- TX
- Lot, serial or model codes
- Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL
- 510(k) numbers
- ["K050228"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- 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