Day

January 26, 2022
Company: Konica Minolta Healthcare Americas, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC Recall Number: Z-0500-2022 REASON lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT 1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 Recall Number: Z-0515-2022 REASON Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe...
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