—#89088

Product

Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. 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.

FDA product code: FTD — Lamp, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K013242
Affected lot / code info: Serial Numbers 0428102135-0428307020

Why it was recalled

Premature Bulb Failure

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060

Distribution

Distribution pattern: 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, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.

Timeline

Recall initiated: 2010-02-23
Posted by FDA: 2010-04-01
Terminated: 2012-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.