Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. T
FDA device recall Z-2180-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
- Action taken
- An "Urgent Safety Notice" letter was sent to all the sites using potentially affected units on/about June 4, 2008. Dealers were notified via letter on June 9, 2008. The letter requests that all users be reminded that Agfa recommends the system is configured so that demographic information is not removed from the image viewing area. They will be provided with the appropriate Service Update, based on the current version of IMPAX Client 6.x in use at their site. They were advised to distribute the information within their facility to all those who need to be aware of it. 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. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 371 units
- Distribution
- U.S., Canada, Europe, Asia Pacific and Latin America.
- Date initiated
- 2008-06-04
- Date posted
- 2008-09-04
- Date terminated
- 2009-10-09
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO (K022292) | Agfa Corp. | 2002-09-12 |