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U.S. Department of Health and Human Services

Class 2 Device Recall MAC VU360

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 Class 2 Device Recall MAC VU360see related information
Date Initiated by FirmJune 28, 2019
Create DateJuly 23, 2019
Recall Status1 Terminated 3 on April 13, 2021
Recall NumberZ-2060-2019
Recall Event ID 83270
510(K)NumberK173830 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductMAC VU360, Model Number 2030360-001, Electrocardiograph
Code Information UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU218450037SA VU218450037SA 840682125499VU218450041SA VU218450041SA 840682125499VU218450042SA VU218450042SA 840682125499VU219170004SA VU219170004SA 840682125499VU219130019SA VU219130019SA 840682125499VU219130032SA VU219130032SA 840682125499VU219130039SA VU219130039SA 840682125499VU219130044SA VU219130044SA 840682125499VU219120048SA VU219120048SA 840682125499VU219120052SA VU219120052SA 840682125499VU219120060SA VU219120060SA 840682125499VU219140016SA VU219140016SA 840682125499VU218440018SA VU218440018SA 840682125499VU219140001SA VU219140001SA 840682125499VU219140005SA VU219140005SA 840682125499VU219120044SA VU219120044SA 840682125499VU219120049SA VU219120049SA 840682125499VU219120054SA VU219120054SA 840682125499VU219120055SA VU219120055SA 840682125499VU219120056SA VU219120056SA 840682125499VU219120012SA VU219120012SA 840682125499VU219120014SA 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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
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
FDA Determined
Cause 2
Software design
ActionThe firm issued an Urgent Medical Device Correction letter on 06/28/2019 to tis consignees by mail. This letter informed the customer of the issues and provides instructions for continued use of the system. GE Healthcare will correct the system by upgrading the software.
Quantity in Commerce369 units
DistributionWorldwide
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 = DQK
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