Company: Philips Medical SystemsDate of Enforcement Report: 11/10/04 Class: II PRODUCT Pagewriter Touch Cardiograph Software. Recall # Z-0063-05. REASON Software can generate printed ECG’s that associate incorrect patient data with the waveform. CODE Software Versions A.01.01 or A.01.02. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is...Read More

Company: Medical Industries America, Inc.Date of Enforcement Report: 11/10/04 Class: II PRODUCT Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 – Consisting...Read More