Recall Z-2618-2024 — Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
U.S. FDA — Device Enforcement · Japan · 2024-07-09 · Class II
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Reported risk: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
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