IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 The IMPAX Cardiovascular suit
FDA device recall Z-0211-2012 · posted 2011-11-18 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
- Action taken
- AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions: Amend the report through the RM interface, or Call AGFA Service to change the status of the report to "preliminary" and then proceed with the finalization of the report. AGFA issued an Acknowledgment, via FAX- Back that the information was received and understood to affected customers. For any questions customers were instructed to contact their AGFA Healthcare Service at 877-777-2432.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 323
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Date initiated
- 2011-06-06
- Date posted
- 2011-11-18
- Date terminated
- 2013-07-02
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |