Device recall
Z-0589-04: All Outpatient and Coolspot single ceiling or single track Medical Examination…
FDA device recall · Class II · Burton Medical Products Corp
Key facts
| Recall number (Z-number) | Z-0589-04 |
|---|---|
| Recall event | 28229 |
| Product | All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL… |
| Product code | KZF |
| Recalling firm | Burton Medical Products Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2012 |
| 510(k) numbers | K851742 |
| FEI number | 2018492 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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