Surgical light heads may detach due to weld defects
DKK Dai-Ichi Shomei is recalling 293 Aurora surgical light heads because the frame welds can crack, potentially causing the light head to detach during use. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a documented risk of detachment during surgical use (a risk-of-harm product). No injuries have been reported. Per the rubric, risk-of-harm products without reported injuries score 3.
Plain-English summary
DKK Dai-Ichi Shomei Co., Ltd. is recalling Aurora 3 Series and Aurora 7 surgical light heads (Model AUT7) used to illuminate the surgical field during procedures. Approximately 293 units distributed worldwide are affected.
The weld on the light head frame can crack. This defect could cause the frame to sag, the plastic front housing to crack, or the light head to detach from its mounting during surgery.
The recalled devices were distributed nationwide in the United States and internationally to Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South Korea, Thailand, UAE, and South America. Healthcare facilities and surgical centers using affected devices should verify their serial numbers against the recall list and stop using any units that fall within the recalled range. Contact the manufacturer for replacement or repair instructions.
The recalled product
- Product
- Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
- Manufacturer
- DKK Dai-Ichi Shomei Co., Ltd.
- Hazard
- weld-cracking
- device-detachment
- structural-failure
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 (20)
- Model Number: AUT7-LH/TV-LH
- Serial Numbers: 13040011
- 13040012
- 13040013
- 13040014
- 13040015
- 13040016
- 13040017
- 13040018
- 13040019
- 13040020
- 13040021
- 13040022
- 13040023
- 13040024
- 13070025
- 13070026
- 13070027
- 13070028
- 13070029
Distribution
Distributed nationwide across the United States.
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