All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. P
FDA device recall Z-0589-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Burton Medical Products Corp
- Reason for recall
- Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
- Action taken
- Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KZF
- Quantity affected
- 17,000 estimated
- Distribution
- Nationwide.
- Date initiated
- 2004-02-19
- Date posted
- 2004-07-20
- Date terminated
- 2012-01-25
- Location
- Chatsworth, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDICAL EXAMINATION LIGHTS (K851742) | Burton Medical Products Corp. | 1985-05-13 |