Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1378-2. REASON Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved. CODE Versions 5.2, 5.23, 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.Firm initiated recall is...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1377-2. REASON Software anomaly. Footnotes are incomplete and do not print on reports. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: Medical Data Electronics, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Defibrillator/ Pacer Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2. REASON Intermittent operation of the paddles. CODE Serial Numbers 10392 thru 10540. RECALLING FIRM/MANUFACTURER Recalling Firm: Medical Data...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Aeroset Software Version 1.01ER000. Recall # Z-1352-2. REASON Sample results may be skewed by failure to properly ‘blank’ the sample. CODE Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by telephone...Read More