Device recall
Z-1662-2014: IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1662-2014 |
|---|---|
| Recall event | 68211 |
| Product | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2014 |
| 510(k) numbers | K050228 |
| FEI number | 3001236302 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database