On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott PacemakersRead More

Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...Read More

Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery. Recall Number Z-3049-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error...Read More

Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery Recall Number Z-3050-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that...Read More