Company: Straumann Manufacturing IncDate of Enforcement Report 3/16/2011 Class ll: PRODUCT Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10. Recall # Z-1592-2011 REASON Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. RECALLING FIRM/MANUFACTURER Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by...Read More

There is a specific standard for radiotherapy treatment planning systems, IEC 62083 Edition 2.0 (2009-09-23) Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems. When there is a specific standard, it takes precedent over general standards. IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone...Read More

IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone product does not fall within the scope of IEC 60601-1. A new work item on Healthcare Software Systems was recently approved. This new standard is intended to apply to stand alone software and will have similar (but not necessarily the...Read More

Company: AGFA Corp.Date of Enforcement Report 3/23/2011 Class ll: PRODUCT IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011 REASON A discrepancy in the validation testing which resulted in the product not performing as intended. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by...Read More