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Harmony
STERIS CORPORATION · Model vLED Surgical Lighting System · UDI-DI 00724995151478
1
510(k) clearances
312
Adverse events
12
Recalls
75
Facilities
Description
Ceiling supported surgical lighting system consisting of one or more vLED lightheads.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-11-26 | Steris Corporation | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
| 2012-04-09 | Gulf Fiberoptics, Inc. | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.