Z-1220-2010

Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086...

Name: Z-1220-2010 Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086...
Creator: Steris Corporation
Published: 2010-02-23
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2010-02-23 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. Designed to provide visible immunization of the... on 2010-02-23. The reason FDA records is "Premature Bulb Failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1220-2010
Status: Terminated
Initiated: 2010-02-23
Posted: 2010-04-01
Terminated: 2012-06-04
Recalling firm: STERIS Corporation
Product: Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. 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.
Product code: FTD Lamp, Surgical
Reason for recall: Premature Bulb Failure
Root cause tag: design
FDA 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 in commerce: 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, 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.
Product codes and lots: Serial Numbers 0436005042-0430207104

Product code FTD

K013242Class IIAmsco Harmony Surgical Lighting and Media SystemSTERIS Corporation / cleared 2001-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)