IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
FDA device recall Z-1676-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- A discrepancy in the validation testing which resulted in the product not performing as intended.
- Action taken
- AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- One
- Distribution
- TX
- Date initiated
- 2011-02-10
- Date posted
- 2011-03-16
- Date terminated
- 2011-09-15
- 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 |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |