medical Class II Updated 2018-06-13

MEDTECH SAS recalls ROSA(TM) Robotized Stereotactic Assistant, Version 2.5

Recalled 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 a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Hazard / Issue

Replacement of units lacking an updated device approval.

Issued by

FDA

Distribution: US Distribution

Lot/Code Info: 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, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069

View official government recall

Were you affected by this recall?

If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Get the next US recall alert before it hits the news.

Free. Weekly digest or instant alerts. Unsubscribe anytime.

CAN-SPAM compliant · No spam · Unsubscribe anytime