Recall of Pro-Med DORO Easy-Connect Navigation Adaptor (item 1204.002) due to potential compatibility issues affecting brain surgery navigation systems. Affected units include specific serial numbers listed.
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Pro-Med Instruments is recalling its DORO Easy-Connect Navigation Adaptor (item 1204.002) because it may cause errors in brain surgery navigation systems. This could lead to incorrect positioning of surgical tools and affect the navigation system's function during procedures.
The adaptor may not work properly with certain brain surgery navigation systems, potentially causing incorrect positioning of surgical tools and disrupting the navigation system's function during procedures. This could lead to inaccurate surgical guidance.
Surgical teams using this adaptor in brain surgery procedures are most at risk. Patients undergoing neurosurgery with this specific model may experience positioning errors.
Check for the model number 1204.002 on the adaptor. Affected units have specific serial numbers listed in the recall notice, including many combinations starting with 1102010 through 2409004.
Verify the model number on the adaptor is 1204.002.
Reach out to Pro-Med Instruments for specific guidance on affected units.
The recall indicates potential compatibility issues that could affect surgical navigation, but no specific injuries have been reported. The risk is low for most users.
Check for the model number 1204.002 and verify the serial number against the list provided in the recall notice.
Contact Pro-Med Instruments directly to confirm if your unit is affected and get specific instructions.
We’ve drafted a message you can send Pro-Med Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-1860-2025 — Pro-Med Instruments Pro-Med Instruments Hello, I own a Pro-Med Instruments that is covered by recall Z-1860-2025 from Pro-Med Instruments. 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.
