August 10, 1998
7/20/98 Hewlett Packard Image Point Ultrasound System Model 2410A used in ultrasound imaging to determine stenosis of the sarotid artery. Software Revisions A.0.0 A.0.1, and A.0.1.2. Class II 441 units. Software overestimates peak blood velocity by 15-25% in some Doppler examinations with the Model 2135A transducer. Recall #=Z-160-8.
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8/10/98 ACS Centaur Automated Chemiluminescence System 29 units with Software Version 1.0-1.2 The test results will be innacurate if the user changes the reporting units and/or slope and intercept for a test. Z-490-9.
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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