Device recall
Z-0831-2012: Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA…
FDA device recall · Class II · Gulf Medical Fiberoptics, Inc.
Key facts
| Recall number (Z-number) | Z-0831-2012 |
|---|---|
| Recall event | 58983 |
| Product | Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics… |
| Product code | FST |
| Recalling firm | Gulf Medical Fiberoptics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2012 |
| 510(k) numbers | K061690 |
| FEI number | 3003768921 |
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