FDA Device recall Z-0930-2015
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variabl…
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variabl… by Steris, citing STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-26 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | AK, AL, AR, CA, DC, FL, IL, IN, KS, LA, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA |
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.
Reason
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Identifiers
| code_info | The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B…The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2015%22
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