The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2621-2024·Announced 2024-08-21

Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk

Aurora Series surgical light heads are recalled due to cracked welds on the frame. The defects can cause the frame to sag, 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: FDA Class II recall involving structural failure of critical surgical equipment. The cracked weld presents a risk of light head detachment during surgery, which could compromise patient visibility and potentially cause injury, though no illnesses or injuries have been reported.

Plain-English summary

DKK Dai-Ichi Shomei Co., Ltd. is recalling Aurora 4 Series and Aurora 7 surgical light heads (model AUA7, including TV models). These devices are intended to illuminate surgical fields and ensure visibility of surgical sites. Approximately 538 units have been distributed domestically throughout the United States and internationally.

The weld on the light head frame can crack, which could lead to the light head frame sagging, the plastic front face housing cracking, or the light head detaching. A defective or detached light head during surgery could compromise surgical visibility or create a risk of injury to patients or surgical staff.

Affected units were distributed to healthcare facilities in the United States and internationally to Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, and the United Arab Emirates.

Healthcare facilities should verify whether they have devices with the affected serial numbers and contact the manufacturer for further instructions regarding replacement, repair, or return of the recalled units.

The recalled product

Product
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.
Manufacturer
DKK Dai-Ichi Shomei Co., Ltd.
Category
Medical Device — Surgical Lighting
Hazard
Affected units
538

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: AUA7-LH/7TV-LH
  • UDI-DI: 10841736100025
  • Serial Numbers: 07120133
  • 2015-03-0001
  • 2015-03-0002
  • 2015-03-0003
  • 2015-03-0004
  • 2015-03-0005
  • 2015-03-0006
  • 2015-03-0007
  • 2015-03-0008
  • 2015-03-0009
  • 2015-03-0010
  • 2015-04-0011
  • 2015-04-0012
  • 2015-04-0013
  • 2015-04-0014
  • 2015-04-0015
  • 2015-04-0016
  • 2015-04-0017

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 →

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