Agency classClass IIOur severity:High FDA (Devices)·Z-2618-2024·Announced 2024-08-21

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.

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 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.
Category: Medical Device — Surgical Lighting
Hazard: weld-failure
device-detachment
structural-cracking
Affected units: 555

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.

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
Surgical light heads may detach due to weld defects
FDA (Devices) · 2024-08-21
High
Surgical Lights Recalled for Possible Weld Defect and Frame Detachment
FDA (Devices) · 2024-08-21
High
Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk
FDA (Devices) · 2024-08-21
High
Medical Device Recall: LFS Flat Screen Support Arm Bracket Failure
FDA (Devices) · 2023-10-11
High
LFS flat screen arm system surgical lamp bracket stopper block defect
FDA (Devices) · 2023-10-11

Same hazard · weld failure