Device recall
Z-3235-2017: NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code…
FDA device recall · Class II · NOVADAQ TECHNOLOGIES INC.
Key facts
| Recall number (Z-number) | Z-3235-2017 |
|---|---|
| Recall event | 77901 |
| Product | NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC… |
| Product code | MMP |
| Recalling firm | NOVADAQ TECHNOLOGIES INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2017 |
| 510(k) numbers | K041501 |
| FEI number | 3012345110 |
At a glance
- 1–9 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