FDANovember 26, 2014device
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
What to do
FDA enforcement status: Terminated
Brands named
mazor roboticsmazor
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMazor X robotic guidance system REF: TPL00592025-12-10
- FDAMazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument2024-07-17
- FDAMAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.12023-09-05
- FDATrexo Device2023-05-31
- CPSCModular Robotics Recalls Rechargeable Battery Packs Due to Burn Hazard2020-04-30
- FDASnapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 072901091818682019-07-02
- FDAi.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E4544482016-11-23
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