Steris Recalls Harmony vLED Surgical Lighting Systems Due to Inconsistent Illumination
Steris is recalling 140 Harmony vLED Surgical Lighting Systems because LED modules may illuminate inconsistently. The units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is inconsistent illumination, which is a functional defect rather than a direct physical injury risk like fire or shock. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Steris Corporation is recalling 140 units of the Harmony vLED Surgical Lighting System. The recall was initiated because the company learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
The affected product is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for operating room staff. The recall includes specific item numbers: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
The units were distributed worldwide, including to various U.S. states and territories, as well as internationally to Canada, China, Greece, Indonesia, the Republic of Korea, Romania, the Russian Federation, Taiwan, and Viet Nam. The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for this recall.
The recalled product
- 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…
- Manufacturer
- Steris Corporation
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- The following item numbers are included in this recall: B136824175
- B136824176
- B136824177
- B136824178
- B136824179
- B136824427
- B136824430
- B136824431
- LK01N
- and LK05N.
Distribution
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