Device recall
Z-0945-2009: IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-0945-2009 |
|---|---|
| Recall event | 50755 |
| Product | IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information… |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2010 |
| 510(k) numbers | K022292 |
| 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