Device recall
Z-1503-2017: Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT…
FDA device recall · Class II · Ohmeda Medical
Key facts
| Recall number (Z-number) | Z-1503-2017 |
|---|---|
| Recall event | 76283 |
| Product | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital |
| Product code | LBI |
| Recalling firm | Ohmeda Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2018 |
| 510(k) numbers | K011549 |
| FEI number | 1121732 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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