MEDTECH SAS recalls ROSA Robotized Stereotactic Assistant Version 2.5 due to outdated device approval. Affected units have specific serial numbers listed. No remedy is provided in the recall notice.
Replacement of units lacking an updated device approval.
MEDTECH SAS is recalling certain versions of their ROSA Surgical Device because they lack an updated device approval. This could pose a risk if the device is used without the latest regulatory clearance.
The device requires updated regulatory approval to ensure safe operation in the operating room. Without this approval, there is a potential risk of improper function during neurosurgical procedures.
Neurosurgeons who own or use the recalled ROSA Surgical Device Version 2.5 are most at risk. The recall affects specific units with listed serial numbers.
Check if your ROSA Surgical Device has a serial number starting with RO followed by numbers (e.g., RO 10 009). The recall includes specific serial numbers listed in the notice.
Identify the serial number on your ROSA Surgical Device to see if it matches the list of affected units provided in the recall notice.
The recall is due to replacement of units lacking an updated device approval. This ensures the device meets current safety and regulatory standards.
The recall notice does not specify a remedy. You should check the serial number against the list provided to determine if your device is affected.
The recall indicates a risk of outdated device approval, but the specific hazard mechanism is not detailed in the notice.
We’ve drafted a message you can send MEDTECH SAS to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2018 — MEDTECH SAS MEDTECH SAS Hello, I own a MEDTECH SAS that is covered by recall Z-2108-2018 from MEDTECH SAS. 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.
