February 28, 2000
PRODUCT SoftBank LIS or Softbank Laboratory Information System. Recall #B-692-0. REASON There is no way of assuring that ADT-Interface transactions will always include correct patient data. CODE All versions installed in computer systems. MANFACTURER Soft Computer Consultants, Palm Harbor, Florida. RECALLED BY Manufacturer, by letters dated February 28, 2000, followed by visit. Firm-initiated field correction...
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PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras. Recall #Z-515-0. REASON During 360 degree SPECT, the resulting image will appear flipped left to right. CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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