Recall Z-1219-2010 ยท FTD Lamp, Surgical
Steris Corporation
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
| Date | Apr 1, 2010 (initiated Feb 23, 2010) |
| Status | Terminated |
| Reason | Premature Bulb Failure |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 344 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, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS Corporation, Dec 13, 2001 |