FDASeptember 5, 2023device
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software update
What to do
FDA enforcement status: Ongoing
Brands named
mazor roboticsmazor
UPCs
072901091804654002611201640027112016400291220164003012201640031122016400361220164003812201640044022017400470220174004802201740050032017
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
- 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
- FDACarousel 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...2014-11-26
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