LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3...
FDA Device Recall #Z-0071-2024 — Class II — August 23, 2023
Recall Summary
| Recall Number | Z-0071-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 23, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DKK Dai-Ichi Shomei Co., Ltd. |
| Location | Itabashi, N/A |
| Product Type | Devices |
| Quantity | 256 units |
Product Description
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
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.
Distribution Pattern
US States: MI
Lot / Code Information
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
Other Recalls from DKK Dai-Ichi Shomei Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2618-2024 | Class II | Aurora Series, Aurora 7 lighthead; Models: LED7... | Jul 9, 2024 |
| Z-2621-2024 | Class II | Aurora 4 Series, Aurora 7 lighthead; Models: AU... | Jul 9, 2024 |
| Z-2620-2024 | Class II | Aurora 3 Series, Aurora 7 lighthead; Models: AU... | Jul 9, 2024 |
| Z-2619-2024 | Class II | Aurora 2 Series, Aurora 7 lighthead; Models: AU... | Jul 9, 2024 |
| Z-0072-2024 | Class II | LFS Flat screen support arm systems without sur... | Aug 23, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.