Device recall
Z-3234-2017: NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape)…
FDA device recall · Class II · NOVADAQ TECHNOLOGIES INC.
Key facts
| Recall number (Z-number) | Z-3234-2017 |
|---|---|
| Recall event | 77901 |
| Product | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after… |
| 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