FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX RIS QDOC 5.8
- Recall number
- Z-0919-2014
- Recalling firm
- AGFA Corp.
- Product
- IMPAX RIS QDOC 5.8
- Status
- Terminated
- Initiated
- 2014-01-08
- Posted
- 2014-02-03
- Terminated
- 2014-02-28
- Reason
- Patient name displayed (printed) on the Patient Report was the wrong patient name.
- Root cause
- Unknown/Undetermined by firm
- Action
- On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
- Quantity
- 14
- Distribution
- CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
- Lot, serial or model codes
- Software IMPAX RIS 58 and higher
- 510(k) numbers
- ["K111945"]
- 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