This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
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Company: Agfa-Gevaert, N.V. Date of Enforcement Report: 1/7/2019 Class II PRODUCT DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class II PRODUCT GE Magnetic Resonance System Various GE Magnetic Resonance System on-site software version. Product Usage: Magnetic resonance imaging equipment for general diagnostic use. Recall Number: Z-0693-2019 REASON Possible incorrect software version loaded. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on 11/15/2018. Voluntary: Firm Initiated...
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Company: Medtronic Inc. Date of Enforcement Report: 12/22/2018 Class II   PRODUCT Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) Recall Number: Z-0683-2019   REASON Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or...
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Company: bioMerieux, Inc. Date of Enforcement Report: 12/19/2018 Class II PRODUCT VITEK 2 Systems Software Version 9.01 Update Kit. Recall Number: Z-0639-2019 REASON The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP” feature. RECALLING...
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Company: COVIDIEN LLC Date of Enforcement Report: 12/18/2018 Class I PRODUCT Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan Bennett” 980 Neonatal Ventilator Puritan Bennett” 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who...
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