The Recall Desk
HighFDA (Devices)·Z-0071-2024·Announced 2023-10-11

LFS flat screen arm system surgical lamp bracket stopper block defect

The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.

What this means for you

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 a risk-of-harm medical device (surgical lamp system) where the potential hazard is spring shaft failure, but no injuries have been reported. FDA Class II classification without reported incidents supports Score 3 under the rubric.

Plain-English summary

The LFS flat screen arm system with surgical lamp, including multiple model numbers across the Aurora series (Aurora, Aurora 2, Aurora 3, Aurora 4, Aurora Astro) and Stellar series (Stellar XL, Stellar), is being recalled due to a defect in the bracket stopper block.

The stopper block on the LFS bracket in affected units is broken or missing. Without this stopper block, the flat screen can rotate beyond its original angle limit. This excessive rotation applies dangerous force to the spring shaft, which could break and shear off.

256 units with specific serial numbers have been identified as affected. These units were distributed in Michigan. Facilities using these systems should check their equipment against the provided serial number list to determine if their units are involved.

If you have an affected unit, contact the manufacturer DKK Dai-Ichi Shomei Co., Ltd. for repair or replacement. Do not use affected units until the stopper block defect has been corrected.

The recalled product

Product
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFS
Manufacturer
DKK Dai-Ichi Shomei Co., Ltd.
Hazard
  • structural-defect
  • spring-shaft-failure

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)

  • Serial Numbers: 06087323 - 06087352
  • 06087353 - 06087354
  • 06081292 - 06081293
  • 06087448 - 06087449
  • 06087450 - 06087469
  • 06097595 - 06097596
  • 06107716 - 06107718
  • 06107719 - 06107728
  • 06107730
  • 06107731 - 06107732
  • 06111348 - 06111349
  • 06117855 - 06117856
  • 06117857 - 06117866
  • 06117868 - 06117868
  • 06111350 - 06111351
  • 06117949 - 06117949
  • 06117954 - 06117973
  • 06118031 - 06118032
  • 06128116 - 06128131
  • 06128172 - 06128176

Distribution

Distributed in 1 state:

  • MI