Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactu
FDA device recall Z-0532-2007 · posted 2007-02-22 · Terminated
Recall details
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Reason for recall
- If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Action taken
- The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTD
- Quantity affected
- 5,000 for all models.
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-01-08
- Date posted
- 2007-02-22
- Date terminated
- 2009-11-18
- Location
- Grand Rapids, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKYTRON INFINITY SERIES SURGICAL LIGHTS (K915285) | Skytron, Div. the Kmw Group, Inc. | 1992-02-20 |