Company: Siemens Medical Solutions USADate of Enforcemet Report: 8/14/02 Class: I PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. REASON Incorrect image time stored for static images resulting in incorrect results. CODE e.soft software version 2.0 installed...Read More
On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule. A copy of the new rule can be view here: HIPAA Modified Final Privacy Rule 2002-08. Medical Device manufacturers that produce devices that will maintain patient...Read More
Company: Baxter Healthcare CorpDate of Enforcement Report: 8/14/02 Class: I PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. REASON Software allows ingredient concentration errors during compounding. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.