NeuroLogica recalls GM85 Digital Mobile X-ray imaging systems with model number GM85 due to risk of bolts loosening or fracturing, potentially causing equipment failure.
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
NeuroLogica is recalling its GM85 Digital Mobile X-ray imaging systems because four bolts securing the tube head unit to the arm may loosen or fracture over time due to metal fatigue. This could lead to equipment failure during use.
The four M5 bolts that hold the tube head unit to the arm can loosen or break because of metal fatigue. This could cause the tube head to detach during use, potentially leading to equipment failure or injury.
Healthcare facilities and medical professionals who use the GM85 Digital Mobile X-ray imaging system are most at risk. The specific model numbers listed in the recall are for systems sold in the U.S. and Canada.
Check for the model number GM85 on the device. The serial numbers listed in the recall include a mix of 514 and 513 prefixes followed by specific codes.
Compare your device's serial number to the list of affected serial numbers provided in the recall.
The four M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Check your device's serial number against the list of affected serial numbers provided in the recall. If it matches, contact NeuroLogica for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should contact NeuroLogica for guidance.
We’ve drafted a message you can send NeuroLogica to request your refund or repair — edit it as you like.
Subject: Recall Z-0480-2026 — NeuroLogica NeuroLogica Hello, I own a NeuroLogica that is covered by recall Z-0480-2026 from NeuroLogica. 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.
