IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital s
FDA device recall Z-1069-2013 · posted 2013-04-08 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Software design error in IMPAX CV 7.8 SU3
- Action taken
- AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers. If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2
- Distribution
- Distribute in the state of FL and KY
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-08
- Date terminated
- 2014-04-01
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |