Company: MEDTECH SAS Date of Enforcement Report: 11/3/2021 Class I PRODUCT ROSA One 3.1 Brain application: The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. Recall Number: Z-0118-2022 REASON The firm has...Read More

Company: AB SCIEX Date of Enforcement Report: 11/3/2021 Class II PRODUCT Cliquid MD (Version 3.4) software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288 Recall Number: Z-0175-2022 REASON The values of the Internal Standard (IS) concentrations are incorrectly derived when the...Read More

Company: Xstrahl Limited Date of Enforcement Report: 11/3/2021 Class II PRODUCT Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy – 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy – 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 – 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl...Read More

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...Read More