Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. Designed to p
FDA device recall Z-1220-2010 · posted 2010-04-01 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- Premature Bulb Failure
- Action taken
- STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FTD
- Quantity affected
- 3,953 units
- Distribution
- Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq
- Date initiated
- 2010-02-23
- Date posted
- 2010-04-01
- Date terminated
- 2012-06-04
- Location
- Mentor, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242) | STERIS Corporation | 2001-12-13 |