Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0638-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....Read More

Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0637-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....Read More

Company: Roche Diagnostics CorporationDate of Enforcement Report 2/28/2018 Class lI: PRODUCT Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 Recall Number Z-0675-2018 REASON A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corporation, Indianapolis, IN on 4/28/2017. Voluntary:...Read More

Company:Med Tec Inc Date of Enforcement Report 2/28/2018 Class lI: PRODUCT Protura Software which utilizes Elekta’s iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch.....Read More

Company:Oculus Optikgeraete GMBH Date of Enforcement Report 2/28/2018 Class lI: PRODUCT OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye Recall Number Z-0635-2018 REASON...Read More