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| Class 2 Device Recall MAC VU360, Electrocardiograph |
Date Initiated by Firm | October 27, 2020 |
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Date Posted | December 07, 2020 |
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Recall Status1 | Open3, Classified |
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Z-0543-2021 |
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| Recall Event ID | 86725 |
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K173830 |
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| Electrocardiograph - Product CodeDPS
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| Product | MAC VU360, Electrocardiograph |
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Code Information | Model: 2030360 001 |
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Recalling Firm/ Manufacturer | GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | GE Healthcare Service 800-437-1171 |
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Incorrect patient identification and/or patient demographic errors. |
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Use error |
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On 10/27/2020 the firm sent a letter to its consignees with the following instructions: You can continue to use your MAC VU360 system: At system setup: -Disable Auto-ECG in System Settings until the software has been upgraded. When performing ECGs: - Ensure the current patient lead wires are disconnected before selecting the Start New Patient workflow in the user interface. - Verify there are live scrolling waveforms on the screen before acquiring an ECG on the patient. - Verify the date and time of the ECG report corresponds to the patient for whom you are acquiring the ECG. - Always enter patient demographic data for each patient before acquiring an ECG GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the MAC VU360 software to be updated. Providing GE Healthcare with an email address in the attached customer response form, allows us to deliver this software update to you electronically and provide you with notifications of future software updates, as they become available. Note: After the MAC VU360 has been updated, discontinue usage of and destroy any media containing MAC VU360 V1.01 SP06 and any prior versions of MAC VU360 software. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
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5,284 units |
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Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom. |
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TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. |
510(K) Database | 510(K)s with Product Code = DPS and Original Applicant = GE Medical Systems Information Technologies, Inc.
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If you are looking for Vu360, you have come to the right place. We explain what Vu360 is and point you to the official download.
What is Vu360?
Vu360 Pricing
Vu360 is software developed by Pathfinder Software originally for contractors accessing documents from BB-Bid, an online plan room dedicated to information and documents on construction. The program allows the user to view documents such as blueprints in PDF, TIFF and HTML Web page formats.
The program’s features also include adding annotations and markups on the blueprints, which are then loaded back to the online plan room for other users to view. Basically, the program serves as a collaboration tool that allows contractors, architects and developers to access, view, annotate and markup blueprints.
The program integrates with Blue Book of Building and Construction website (thebluebook.com), an online resource for everything on construction. This allows the user to instantly access and view documents and other information from sub-contractors and developers including construction estimates.
Vu360 is a Microsoft .NET Framework program that can export documents to MS Excel or XML. The user needs to register first prior to utilizing the program. It also comes with a built-in Web browser to allow for easier access to online construction information.
Download Vu360 from the developer
File.org does not provide software hosting. We send you directly to the developer's site, to make sure you download the latest, original version of the program.
Vu360 Solutions
File types supported by Vu360
Vu360 Ecg
Murgee auto clicker payment. Our users primarily use Vu360 to open these file types:
About file types supported by Vu360
File.org aims to be the go-to resource for file type- and related software information. We spend countless hours researching various file formats and software that can open, convert, create or otherwise work with those files.
If you have additional information about which types of files Vu360 can process, please do get in touch - we would love hearing from you.