Aurora 4 Series, Aurora 7 lighthead recallZ-2621-2024 · DKK Dai-Ichi Shomei Co., Ltd. · initiated Jul 9, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from DKK Dai-Ichi Shomei Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On July 9, 2024 URGENT: Aurora 7 Lighthead Series RECALL letters were sent to customers. Actions to be taken by the customer: Contact the end users and tell them to discontinue the use of the product. Please send an acknowledgement letter or email to Dai-ichi Shomei to let us know that you have received this Field Action Advisory Notice within 3 days after you receive the Notice. Actions to be Taken by the Manufacturer: The physical correction will be announced later. Contact information for questions: email [email protected]

Recall details

Recall number: Z-2621-2024
Status: Open, Classified
Initiated by the company: Jul 9, 2024
Posted by the FDA: Aug 14, 2024
Recalling firm: DKK Dai-Ichi Shomei Co., Ltd.
Quantity: 538 units
Product code: FSY
FDA submissions: K071698
Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

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.

Code information (models, lots, serial numbers)

Show the full code information (8k characters)

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Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Aurora Surgical Light Series Aurora Four
Skytron LLC · Light, surgical, ceiling mounted
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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