The 1998 2nd edition of the standard UL 1998 Software in ProgrammableComponents was reaffirmed and reissued Oct 28, 2008. There were no substantive changes. This is one of the few software standards recognized by FDA.Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/29/2008 Class:ll PRODUCT Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479, Recall # Z-2468-2008 REASON As a result of bugs and calculation errors,...Read More

Company: Philips Medical Systems Date of Enforcement Report 10/29/2008 Class:lll PRODUCT Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient, Recall # Z-2369-2008 REASON Software: If Weight Limits...Read More