Recall Z-2621-2024— DKK Dai-Ichi Shomei Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by DKK Dai-Ichi Shomei Co., Ltd., initiated 2024-07-09. It names one FDA 510(k) clearance: K071698. Product: Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.. Reason: 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..
- Recalling firm
- DKK Dai-Ichi Shomei Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-09
- Firm location
- Itabashi, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.