Company: Toshiba American Medical Systems IncDate of Enforcement Report 2/23/2011 Class ll: PRODUCT Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) – Whole Body X-Ray CT Scanner. Recall # Z-1257-2011 REASON Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV....Read More

Company: GE Healthcare ITDate of Enforcement Report 2/23/2011 Class ll: PRODUCT GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to...Read More