Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames
DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.
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 of surgical lighting equipment. The weld defect presents a risk of equipment detachment during surgery, but no injuries or illnesses have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DKK Dai-Ichi Shomei Co., Ltd. is recalling 555 units of the Aurora Series surgical light head (Model LED7, including TV models). This device is intended to illuminate the surgical field and provide visibility during surgical procedures.
The weld on the light head frame can crack. If cracking occurs, it can cause the light head frame to sag, the plastic front face housing to crack, or the light head to detach completely.
The affected units were distributed nationwide in the United States and internationally to Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, the Netherlands, New Zealand, the Philippines, Singapore, South America, South Korea, Thailand, and the United Arab Emirates. Specific serial numbers are documented in the FDA recall notice. Hospitals and surgical facilities should stop using affected devices and contact DKK Dai-Ichi Shomei Co., Ltd. for replacement or repair instructions. No illnesses or injuries have been reported.
The recalled product
- Product
- 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.
- Manufacturer
- DKK Dai-Ichi Shomei Co., Ltd.
- Hazard
- weld-failure
- device-detachment
- structural-cracking
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: LED7-LH/7TV-LH
- Serial Numbers: 7010002
- 7010003
- 7010004
- 7010005
- 7010006
- 7030007
- 7030008
- 7030009
- 7030010
- 7030011
- 7030012
- 7030013
- 7030014
- 7030015
- 7030016
- 7030017
- 7030018
- 7030019
- 7030020
Distribution
Distributed nationwide across the United States.
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