Z-0930-2015Class II

Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is...

Name: Z-0930-2015 Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is...
Creator: Steris Corporation
Published: 2014-11-26
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2014-11-26 / Terminated / root cause: software

FDA source

Steris Corporation began a recall of Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical... on 2014-11-26. FDA classified it as Class II and gives the reason as "STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0930-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-26
Posted: 2015-01-07
Terminated: 2015-07-11
Recalling firm: STERIS Corporation
Product: Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
Product code: FST Light, Surgical, Fiberoptic
Reason for recall: STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Root cause tag: software
FDA root cause: Software Design Change
Action: STERIS sent an Urgent Voluntary Field Correctionn Notice to all affected consignees via FedEx. The Consignee Notification mailing was initiated the week of December 15, 2014. Customers were instructed that their local STERIS representative would contact their facility to arrange for the installation of updated software. Customers with questions were instructed to call 1-800-548-4873. For questions regarding this recall call 440-392-7231.
Quantity in commerce: 140 units
Distribution: Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russian Federation, Taiwan, and Viet Nam.
Product codes and lots: The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-06

Product code FST

K100395Class IIHarmony Vled Surgical Lightning SystemSTERIS Corporation / cleared 2010-03-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)