Device recall
Z-1374-2011: AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part…
FDA device recall · Class II · AMO Manufacturing USA, LLC
Key facts
| Recall number (Z-number) | Z-1374-2011 |
|---|---|
| Recall event | 56394 |
| Product | AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version Product is manufactured and… |
| Product code | LZS |
| Recalling firm | AMO Manufacturing USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2012 |
| PMA numbers | P930016, P930016S016 |
| FEI number | 3006695864 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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