510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DKK Dai-Ichi Shomei Co., Ltd.

Itabashi-Ku, JP

DKK DAI-ICHI SHOMEI CO, LTD appears in FDA device records in Itabashi-Ku, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
6
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for DKK Dai-Ichi Shomei Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30064375183006437518DKK DAI-ICHI SHOMEI CO, LTD1-32-26, SAKASHITA, ITABASHI-KU Tokyo 174-0043 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2621-2024Aurora 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.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.Class IIOpen, Classified
Z-2620-2024Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.Class IIOpen, Classified
Z-2619-2024Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.Class IIOpen, Classified
Z-2618-2024Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.Class IIOpen, Classified
Z-0072-2024LFS Flat screen support arm systems without 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 Support Arm Model NumbersThe 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.Class IIOpen, Classified
Z-0071-2024LFS 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 ST2319WCThe 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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain