Reported Aug 21, 2024 · Ongoing

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the…

DKK Dai-Ichi Shomei Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DKK Dai-Ichi Shomei Co., Ltd. · 1 Chome 32-26 · Itabashi · N/A

Is this the product you have?

  • Aurora Series, Aurora 7 lighthead
  • ModelsLED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site
Lot codes and dates
  • Model NumberLED7-LH/7TV-LH
  • Serial Numbers

    555 of 555 codes

    • 7010002
    • 7010003
    • 7010004
    • 7010005
    • 7010006
    • 7030007
    • 7030008
    • 7030009
    • 7030010
    • 7030011
    • 7030012
    • 7030013
    • 7030014
    • 7030015
    • 7030016
    • 7030017
    • 7030018
    • 7030019
    • 7030020
    • 7030021
    • 7040022
    • 7040023
    • 7040024
    • 7040025
    • 7040026
    • 7040027
    • 7040028
    • 7040029
    • 7040030
    • 7040031
    • 7040032
    • 7040033
    • 7040034
    • 7040035
    • 7040036
    • 7040037
    • 7070039
    • 7070040
    • 7070041
    • 7070042
    • 7070043
    • 7070044
    • 7070045
    • 7070046
    • 7070047
    • 7070048
    • 7070049
    • 7070050
    • 7080053
    • 7080054
    • 7080055
    • 7080056
    • 7080057
    • 7080058
    • 7080059
    • 7080060
    • 07080061
    • 7080062
    • 7080063
    • 7080064
Amount recalled
555 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.