Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0172-2020 — Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or to

U.S. FDA — Device Enforcement · France · 2019-09-10 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0172-2020
Date of alert: 2019-09-10
Country / jurisdiction: France
Risk level: Class I
Risk type: recall
Brand: MEDTECH SAS
Product category: device
Product type: Devices

Reported risk: The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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