CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
LFS Flat screen arm system with surgical lamp recalled
DKK Dai-Ichi Shomei Co is recalling LFS Flat screen arm system with surgical lamp for, distributed in Michigan. The recall was initiated on 23 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0071-2024
- FDA event ID
- 92999
- Recalling firm
- DKK Dai-Ichi Shomei Co, Itabashi, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2023
- FDA classified
- 5 Oct 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 23 Aug 2023 | Recall initiated by company | |
| 5 Oct 2023 | Classified by FDA | +43 days |
| 11 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
Where it was distributed
US States: MI
Questions about this recall
Is LFS Flat screen arm system with surgical lamp for recalled?
Yes. DKK Dai-Ichi Shomei Co recalled LFS Flat screen arm system with surgical lamp for on 23 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0071-2024.
Why was it recalled?
The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.
Which lots are affected?
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, 06128177 - 06128186, 06128187 - 06128188, 07010004, 07010002, 07010005 - 07010006, 07028436 - 07028441, 07030080 - 07030081, 07048491 - 07048495, 07058506 - 07058507, 07058508 - 07058512, 07068602 - 07068604, 07068605 - 07068607, 07068611 - 07068622, 07068609 - 07068610, 07068667 - 07068670, 07061479 - 07061484, 07078679 - 07078680, 07071485 - 07071488, 07071501, 07088741 - 07088742, 07081124, 07088766, 07098769 - 07098773, 07098767 - 07098768, 07098774 - 07098775, 07108885 - 07108889, 07108883 - 07108884, 07108876 - 07108882, 07108890 - 07108891, 07101533 - 07101534, 07129027 - 07129028, RA000182, RA000184, 08029174 - 08029183, 08029187 - 08029188, 08029189 - 08029190, 09111694, 10011776, 10011777, 10011778, 10011779, 10011780, 10011781, 10011782, 10051792, 10051794, 10051796, 10051798, 10051800, 10051802, 10051804, 100610044, 100610045, 100610046, 100610047, 100610048, 100610049, 100610050, 100610051, 100610052, 100610053, 101010180, 101010182, 101010184, 101010186, 101010188, 101010190, 101010192, 101210252, BM005435 - BM005435, BM006121 - BM006121, BM008121 - BM008127
Where was it sold?
US States: MI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DKK Dai-Ichi Shomei Co
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aurora 2 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | Aurora 3 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | Aurora 4 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | Aurora Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | LFS Flat screen support arm systems without surgical lamp recalled | DKK Dai-Ichi Shomei Co | Device Malfunction | MI |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |