DKK Dai-Ichi Shomei recalls Aurora 7 lighthead models (LED7) due to potential weld cracks causing frame sagging or detachment during surgery.
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.
DKK Dai-Ichi Shomei is recalling Aurora 7 lighthead surgical lights with model numbers starting with LED7. The weld on the light head frame can crack, leading to sagging, cracking of the plastic housing, or detachment during surgery.
The weld on the light head frame can crack over time, which may cause the frame to sag, the plastic front housing to crack, or the entire light head to detach from the surgical instrument. This could compromise the light's stability during surgery.
Surgical staff using the Aurora 7 lighthead models (LED7) for operating rooms. Patients and staff at hospitals using these lights are most at risk during procedures.
Check for model numbers starting with LED7 (including TV models) on the product. Serial numbers listed in the recall include many numbers from 7010002 to 8100398 and beyond.
Look for model numbers starting with LED7 on the lighthead or TV model.
If your product has a serial number in the list provided, stop using it immediately to prevent detachment during surgery.
The recall includes Aurora 7 lighthead models with serial numbers starting from 7010002 up to 8100398 and beyond as listed in the record.
Yes, the recall states that the light head could detach due to weld cracks, which might compromise surgical visibility.
The hazard involves potential frame sagging or detachment during surgery, which could affect surgical visibility but does not explicitly mention injury risk.
We’ve drafted a message you can send DKK Dai-Ichi Shomei to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2024 — DKK Dai-Ichi Shomei DKK Dai-Ichi Shomei Hello, I own a DKK Dai-Ichi Shomei that is covered by recall Z-2618-2024 from DKK Dai-Ichi Shomei. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
