Company: Elekta Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Elekta Monaco – Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-2563-2021 REASON Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to...Read More
Company: Biodex Medical Systems, Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. Recall Number: Z-2580-2021 REASON When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.