Product Wiki · Recalls · U.S. FDA — Device Enforcement

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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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2618-2024
Date of alert
2024-07-09
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
DKK Dai-Ichi Shomei Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07080061
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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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