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The letter notes no reported injuries, explains risks of delayed recognition of clinically significant events, and provides customer actions, affected product identification, intended use, and document retention plus an electronic or mailed acknowledgement response due within 30 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Healthcare Administrator / Risk Manager  \nChief of Nursing  \nDirector of Biomedical Engineering  \nRE: Carescape™ Central Station (CSCS) V3.0.x  \nSafety Issue  \nGE HealthCare has become aware that the Carescape Central Station (CSCS) V3.0.x may not resume patient monitoring for at least 3 minutes following a system restart. This situation can arise only when the Allow list database is corrupted message is displayed in the title bar of the CSCS prior to a system restart. In the unlikely event that this situation occurs, it can lead to a potential delay in recognition of clinically significant events.  \nThere have been no injuries reported to GE HealthCare as a result of this issue.  \nActions to be taken by Customer/User  \nYou can continue to use your Carescape™ Central Station V3.0.x device by following the instructions below:  \nIf the Allow list database is corrupted message is displayed in the title bar of the CSCS, please follow instructions in the User Manual Addendum (provided in Appendix A of this letter) and contact authorized service personnel.  \nSee Appendix B for a list of part numbers and instructions to download the updated User Manualsand Addendum. If you have difficulty accessing the documentation, please contact GE HealthCare for assistance.  \nPlease ensure your facility is utilizing the latest Carescape™ Central Station (CSCS) V3.0.x User Manual and User Manual Addendum.  \nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions.  \nPlease retain this document for your records.  \nPlease complete and return the attached acknowledgement form electronically via FMI 36173 Digital Response Form or print, fill out manually, scan, and [email to](email to recall36173@gehealthcare.com)[ ](email to recall36173@gehealthcare.com)[recall36173@gehealthcare.com](email to recall36173@gehealthcare.com).  \nAffected Product Details  \nPlease see the table below to identify the affected products. Serial numbers are located on the product label affixed to the back of the Central Station for an integrated unit, and on the back of the CPU (Central Processing Unit) for a desktop unit. Identify the affected product code by locating the 13-digit GE HealthCare serial number.  \nDevice Identifier Table:  \n\n| Product | Product Code | Part Number \\# | GTIN Number |\n| --- | --- | --- | --- |\n| CSCSV3 MAS800 Desktop | STU | 5867474-04 | 00195278343512 |\n|  |  | 5867474-13 | 00195278516367 |\n| CSCS V3 MAI800 Integrated | STV | 5867474-03 | 00195278343383 |\n| Device Serial Number: 13-Digit |  |  |  |\n| XXX XXXXXXXXXX\u003Cbr>Three-digit product code identifier\u003Cbr>|  |  |  |\n\nIntended Use:  \nThe Carescape Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment.  \nThe Carescape Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems.  \nProduct Correction  \nWith this letter (see Appendix A), GE HealthCare is providing an excerpt from the CSCS Addendum for User Manual instructions related to the Allow list database is corrupted message. As noted in the“Actions to be Taken by the Customer” section of this letter, the updated User Manual and Addendum is available on the GE HealthCare Customer Documentation Portal.  \nContact Information  \nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service or your local Service Representative.  \nPlease be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact GE HealthCare per the contact","cbCaitnxdEHbPF5e","https://ap.wps.com/l/cbCaitnxdEHbPF5e","pdf",339471,"English","# Urgent Field Safety Notice\n## Safety Issue and Potential Impact\n## Actions to be Taken by Customer/User\n## Affected Product Details\n## Intended Use and Product Correction\n## Contact Information and Acknowledgement Form\n## Appendix A: Addendum (Software version 3)","[{\"question\":\"What safety issue affects Carescape Central Station (CSCS) V3.0.x after a restart?\",\"answer\":\"CSCS V3.0.x may not resume patient monitoring for at least 3 minutes following a system restart when the title bar shows an “Allow list database is corrupted” message.\"},{\"question\":\"Is there any reported injury related to this issue?\",\"answer\":\"No injuries have been reported to GE HealthCare as a result of this issue.\"},{\"question\":\"What actions must customers/users take and when should they submit acknowledgement?\",\"answer\":\"Follow the User Manual Addendum instructions and contact authorized service personnel if the corrupted allow list message appears, ensure facilities use the latest manuals/addendum, and return the acknowledgement form electronically or by email within 30 days of receipt.\"}]","Carescape Central Station (CSCS) V3.0.x - Urgent Field Safety Notice - FMI 36173 - Actions and Acknowledgement | PDF",15]