Medtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues
Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly states the reason is a lack of updated device approval and does not report any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtech SAS is recalling 29 units of the ROSA Robotized Stereotactic Assistant, Version 2.5. This computer-controlled electromechanical arm is intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments.
The recall was initiated because the affected units lack an updated device approval. The source text does not report any illnesses, injuries, or deaths associated with these devices.
The recall affects 29 specific units distributed in the US. Users should contact Medtech SAS for further instructions regarding the replacement of these units.
The recalled product
- Product
- 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
- Manufacturer
- MEDTECH SAS
- Category
- Medical Device — Surgical Robot
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: RO 10 009
- RO 10 011
- RO 10 014
- RO 13 023
- RO 13 027
- RO 14 031
- RO 14 033
- RO 14 035
- RO 14 038
- RO 14 039
- RO 14 040
- RO 14 041
- RO 14 043
- RO 15 044
- RO 15 045
- RO 15 046
- RO 15 050
- RO 15 051
- RO 15 052
- RO 15 053
Distribution
Distribution scope not specified by the agency.
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