Agency classClass IIOur severity:High FDA (Devices)·Z-2619-2024·Announced 2024-08-21

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category: Medical Device — Surgical Lighting
Hazard: weld-defect
frame-failure
detachment-risk
Affected units: 822

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.

Part of a larger recall action

This product is one of 4 recalled by DKK Dai-Ichi Shomei Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · DKK Dai-Ichi Shomei Co., Ltd.

See all →

High
Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames
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Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk
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Same hazard · weld defect