Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04. REASON Audio alarm may fail to sound when Sp02 limits drop below the set limits. CODE Software versions 2.0 or 2.5. RECALLING FIRM/MANUFACTURER Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002...Read More

Company: Inceptio Medical Technologies LCProduct: “Punctsure Vascular Access Imaging Procedure Kits” and other ultrasonic vascular imaging systems and sterile accesories Date: 7/14/04 Failure to validate a process for which results cannot be fully verified by subsequent inspection or test, [21 CFR 820.75(a)]. Your sterilization process validation for the Punctsure Vascular Access Imaging Procedure Kits is...Read More