April 28, 2006
Company:Neurotone Systems Inc..Product: RelaxPak, Neurotone III and Neurotone III D Cranial Electrotherapy Stimulator Date: 4/10/2006 Failure to establish, and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75. [FDA-483 Item 4). Where the process cannot be fully...
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Company: Boston Scientific Target, Date of Enforcement Report:3/15/2006 Class:lI PRODUCT ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06 REASON Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters...
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