Agency classClass IIOur severity:High FDA (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.

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 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…
Manufacturer: DKK Dai-Ichi Shomei Co., Ltd.
Category: Medical Device — Surgical Equipment
Hazard: structural-defect
spring-shaft-failure
Affected units: 256

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:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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

See all →

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Same hazard · structural defect