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U.S. Department of Health and Human Services

Class 2 Device Recall MAC VU360, Electrocardiograph

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 Class 2 Device Recall MAC VU360, Electrocardiographsee related information
Date Initiated by FirmOctober 27, 2020
Date PostedDecember 07, 2020
Recall Status1 Terminated 3 on May 03, 2024
Recall NumberZ-0543-2021
Recall Event ID 86725
510(K)NumberK173830 
Product Classification Electrocardiograph - Product Code DPS
ProductMAC VU360, Electrocardiograph
Code Information Model: 2030360 001
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		Incorrect patient identification and/or patient demographic errors.
FDA Determined
Cause 2		Use error
ActionOn 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.
Quantity in Commerce5,284 units
DistributionDomestic 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.
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DPS
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