FDAMay 8, 2018device
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Replacement of units lacking an updated device approval.
What to do
FDA enforcement status: Terminated
Brands named
medtech sasmedtech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutane...2025-05-23
- FDAAtalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.2025-04-03
- FDAThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning ...2024-08-05
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST1802024-01-26
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST1752024-01-26
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