Surgical Lights Recalled for Possible Weld Defect and Frame Detachment
DKK Dai-Ichi Shomei Co., Ltd. is recalling 822 Aurora surgical light heads due to a weld defect that could cause the light head to sag, crack, or detach during use.
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 an FDA Class II recall for a structural defect in a surgical light device. While no injuries have been reported, the potential for the light head to detach during surgical procedures constitutes a risk-of-harm product where injury has not yet been realized, fitting the 'High' category.
Plain-English summary
Aurora surgical light heads manufactured by DKK Dai-Ichi Shomei Co., Ltd. are being recalled due to a potential defect in the weld on the light head frame. Approximately 822 units of the Aurora 2 Series and Aurora 7 (Model AUR7) are affected by this recall. These devices were distributed throughout the United States and to international markets including Australia, Canada, Japan, New Zealand, Singapore, and other countries.
A crack in the light head frame weld could cause the frame to sag, the plastic front housing to crack, or the light head to detach from its mounting. These defects could develop during use of the surgical light.
The affected devices have Model Number AUR7-LH/7TV-LH and specific serial numbers provided by the manufacturer. This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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-defect
- frame-failure
- detachment-risk
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: AUR7-LH/7TV-LH
- Serial Numbers: 09010002
- 9020003
- 9020004
- 9020007
- 9020008
- 9020009
- 9020010
- 9020011
- 9020012
- 9020013
- 9020014
- 9020015
- 9020016
- 9030017
- 9030018
- 9030019
- 9030020
- 9030021
- 9030022
Distribution
Distributed nationwide across the United States.
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