March 24, 2021
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/24/2021 Class II PRODUCT Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model...
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Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 3/24/2021 Class II PRODUCT Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01 Recall Number: Z-1254-2021 REASON BeneVision DMS may intermittently freeze and require a...
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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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