IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storag
FDA device recall Z-1245-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Text and Images may not be synchronized.
- Action taken
- AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 154 units
- Distribution
- U.S. Nationwide and Canada
- Date initiated
- 2007-06-28
- Date posted
- 2008-09-11
- Date terminated
- 2011-03-03
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X (K050751) | Agfa Corp. | 2005-04-21 |
| IMPAX CLIENT EMBRACE (K040555) | Agfa Corp. | 2004-05-26 |