Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MAC VU360

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MAC VU360 see related information
Date Initiated by Firm June 28, 2019
Create Date July 23, 2019
Recall Status1 Terminated 3 on April 13, 2021
Recall Number Z-2060-2019
Recall Event ID 83270
510(K)Number K173830  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product MAC 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 VU219120014SA 840682125499VU219120016SA VU219120016SA 840682125499VU219120018SA VU219120018SA 840682125499VU219190012SA VU219190012SA 840682125499VU219130043SA VU219130043SA 840682125499VU218430051SA VU218430051SA 840682125499VU218430052SA VU218430052SA 840682125499VU218430056SA VU218430056SA 840682125499VU218440007SA VU218440007SA 840682125499VU218440010SA VU218440010SA 840682125499VU218450029SA VU218450029SA 840682125499VU218500017SA VU218500017SA 840682125499VU219040005SA VU219040005SA 840682125499VU219040006SA VU219040006SA 840682125499VU218430014SA VU218430014SA 840682125499VU218430058SA VU218430058SA 840682125499VU218430053SA VU218430053SA 840682125499VU218440026SA VU218440026SA 840682125499VU219140036SA VU219140036SA 840682125499VU219170001SA VU219170001SA 840682125499VU219170002SA VU219170002SA 840682125499VU219170009SA VU219170009SA 840682125499VU219130028SA VU219130028SA 840682125499VU219130035SA VU219130035SA 840682125499VU219130042SA VU219130042SA 840682125499VU219140044SA VU219140044SA 840682125499VU219170005SA VU219170005SA 840682125499VU219180020SA VU219180020SA 840682125499VU219180021SA VU219180021SA 840682125499VU219180022SA VU219180022SA 840682125499VU219180024SA VU219180024SA 840682125499VU219180025SA VU219180025SA 840682125499VU219180026SA VU219180026SA 840682125499VU219180027SA VU219180027SA 840682125499VU219180028SA VU219180028SA 840682125499VU219180029SA VU219180029SA 840682125499VU219180031SA VU219180031SA 840682125499VU219180032SA VU219180032SA 840682125499VU219180035SA VU219180035SA 840682125499VU419170013SA VU419170013SA 840682125499VU219140045SA VU219140045SA 840682125499VU219140047SA VU219140047SA 840682125499VU218430025SA VU218430025SA 840682125499VU219090023SA VU219090023SA 840682125499VU219100057SA VU219100057SA 840682125499VU219110011SA VU219110011SA 840682125499VU219130002SA VU219130002SA 840682125499VU219130003SA VU219130003SA 840682125499VU219130050SA VU219130050SA 840682125499VU219140013SA VU219140013SA 840682125499VU218460002SA VU218460002SA 840682125499VU218500014SA VU218500014SA 840682125499VU218500015SA VU218500015SA 840682125499VU219070022SA VU219070022SA 840682125499VU219080003SA VU219080003SA 840682125499VU219080004SA VU219080004SA 840682125499VU219080006SA VU219080006SA 840682125499VU219090001SA VU219090001SA 840682125499VU219090004SA VU219090004SA 840682125499VU219090008SA VU219090008SA 840682125499VU219090009SA VU219090009SA 840682125499VU219090010SA VU219090010SA 840682125499VU219090012SA VU219090012SA 840682125499VU219090013SA VU219090013SA 840682125499VU219090014SA VU219090014SA 840682125499VU219090015SA VU219090015SA 840682125499VU219090017SA VU219090017SA 840682125499VU219090018SA VU219090018SA 840682125499VU219090020SA VU219090020SA 840682125499VU219090021SA VU219090021SA 840682125499VU219090022SA VU219090022SA 840682125499VU219090024SA VU219090024SA 840682125499VU219090026SA VU219090026SA 840682125499VU219090029SA VU219090029SA 840682125499VU219090030SA VU219090030SA 840682125499VU219090031SA VU219090031SA 840682125499VU219090032SA VU219090032SA 840682125499VU219090033SA VU219090033SA 840682125499VU219090034SA VU219090034SA 840682125499VU219090036SA VU219090036SA 840682125499VU219090037SA VU219090037SA 840682125499VU219100002SA VU219100002SA 840682125499VU219100003SA VU219100003SA 840682125499VU219100005SA VU219100005SA 840682125499VU219100006SA VU219100006SA 840682125499VU219100007SA VU219100007SA 840682125499VU219100008SA VU219100008SA 840682125499VU219100009SA VU219100009SA 840682125499VU219100010SA VU219100010SA 840682125499VU219100011SA VU219100011SA 840682125499VU219100013SA VU219100013SA 840682125499VU219100014SA VU219100014SA 840682125499VU219100015SA VU219100015SA 840682125499VU219100016SA VU219100016SA 840682125499VU219100017SA VU219100017SA 840682125499VU219100018SA VU219100018SA 840682125499VU219100019SA VU219100019SA 840682125499VU219100020SA VU219100020SA 840682125499VU219100021SA VU219100021SA 840682125499VU219100022SA VU219100022SA 840682125499VU219100023SA VU219100023SA 840682125499VU219100024SA VU219100024SA 840682125499VU219100025SA VU219100025SA 840682125499VU219100026SA VU219100026SA 840682125499VU219100028SA VU219100028SA 840682125499VU219100029SA VU219100029SA 840682125499VU219100030SA VU219100030SA 840682125499VU219100031SA VU219100031SA 840682125499VU219100032SA VU219100032SA 840682125499VU219100033SA VU219100033SA 840682125499VU219100034SA VU219100034SA 840682125499VU219100035SA VU219100035SA 840682125499VU219100036SA VU219100036SA 840682125499VU219100037SA VU219100037SA 840682125499VU219100038SA VU219100038SA 840682125499VU219100039SA VU219100039SA 840682125499VU219100040SA VU219100040SA 840682125499VU219100041SA VU219100041SA 840682125499VU219100042SA VU219100042SA 840682125499VU219100043SA VU219100043SA 840682125499VU219100044SA VU219100044SA 840682125499VU219100045SA VU219100045SA 840682125499VU219100047SA VU219100047SA 840682125499VU219100048SA VU219100048SA 840682125499VU219100049SA VU219100049SA 840682125499VU219100050SA VU219100050SA 840682125499VU219100051SA VU219100051SA 840682125499VU219100052SA VU219100052SA 840682125499VU219100053SA VU219100053SA 840682125499VU219100055SA VU219100055SA 840682125499VU219100056SA VU219100056SA 840682125499VU219100059SA VU219100059SA 840682125499VU219100060SA VU219100060SA 840682125499VU219100061SA VU219100061SA 840682125499VU219100062SA VU219100062SA 840682125499VU219100063SA VU219100063SA 840682125499VU219100066SA VU219100066SA 840682125499VU219100068SA VU219100068SA 840682125499VU219100069SA VU219100069SA 840682125499VU219100070SA VU219100070SA 840682125499VU219100073SA VU219100073SA 840682125499VU219140015SA VU219140015SA 840682125499VU219140027SA VU219140027SA 840682125499VU219140028SA VU219140028SA 840682125499VU219140030SA VU219140030SA 840682125499VU219140031SA VU219140031SA 840682125499VU219140032SA VU219140032SA 840682125499VU219140033SA VU219140033SA 840682125499VU219140034SA VU219140034SA 840682125499VU219140035SA VU219140035SA 840682125499VU219140037SA VU219140037SA 840682125499VU219140038SA VU219140038SA 840682125499VU219140039SA VU219140039SA 840682125499VU219140040SA VU219140040SA 840682125499VU219140041SA VU219140041SA 840682125499VU219140042SA VU219140042SA 840682125499VU219140043SA VU219140043SA 840682125499VU219140048SA VU219140048SA 840682125499VU219140050SA VU219140050SA 840682125499VU219140051SA VU219140051SA 840682125499VU219140052SA VU219140052SA 840682125499VU219140054SA VU219140054SA 840682125499VU219120020SA VU219120020SA 840682125499VU418500025SA VU418500025SA 840682125499VU418500026SA VU418500026SA 840682125499VU418500027SA VU418500027SA 840682125499VU418500028SA VU418500028SA 840682125499VU418500030SA VU418500030SA 840682125499VU418500031SA VU418500031SA 840682125499VU418500033SA VU418500033SA 840682125499VU418500035SA VU418500035SA 840682125499VU418500036SA VU418500036SA 840682125499VU418510001SA VU418510001SA 840682125499VU419170010SA VU419170010SA 840682125499VU419170012SA VU419170012SA 840682125499VU419170015SA VU419170015SA 840682125499VU419170016SA VU419170016SA 840682125499VU419170017SA VU419170017SA 840682125499VU419170018SA VU419170018SA 840682125499VU419170019SA VU419170019SA 840682125499VU419170021SA VU419170021SA 840682125499VU419170022SA VU419170022SA 840682125499VU419180001SA VU419180001SA 840682125499VU419180003SA VU419180003SA 840682125499VU419180005SA VU419180005SA 840682125499VU419180006SA VU419180006SA 840682125499VU219040017SA VU219040017SA 840682125499VU219060001SA VU219060001SA 840682125499VU219060003SA VU219060003SA 840682125499VU219130027SA VU219130027SA 840682125499VU219130052SA VU219130052SA 840682125499VU219120053SA VU219120053SA 840682125499VU219130011SA VU219130011SA 840682125499VU219130012SA VU219130012SA 840682125499VU219130014SA VU219130014SA 840682125499VU219130021SA VU219130021SA 840682125499VU219130023SA VU219130023SA 840682125499VU219140049SA VU219140049SA 840682125499VU219120010SA VU219120010SA 840682125499VU219120019SA VU219120019SA 840682125499VU219180019SA VU219180019SA 840682125499VU219130005SA VU219130005SA 840682125499VU219130006SA VU219130006SA 840682125499VU219130016SA VU219130016SA 840682125499VU219130018SA VU219130018SA 840682125499VU219130020SA VU219130020SA 840682125499VU219130024SA VU219130024SA 840682125499VU219130033SA VU219130033SA 840682125499VU219130034SA VU219130034SA 840682125499VU219040004SA VU219040004SA 840682125499VU219120050SA VU219120050SA 840682125499VU219130049SA VU219130049SA 840682125499VU219140046SA VU219140046SA 840682125499VU219140055SA VU219140055SA 840682125499VU219140056SA VU219140056SA 840682125499VU219170003SA VU219170003SA 840682125499VU219170007SA VU219170007SA 840682125499VU219120005SA VU219120005SA 840682125499VU219120015SA VU219120015SA 840682125499VU219120023SA VU219120023SA 840682125499VU219130001SA VU219130001SA 840682125499VU219130004SA VU219130004SA 840682125499VU219130022SA VU219130022SA 840682125499VU219130008SA VU219130008SA 840682125499VU218440055SA VU218440055SA 840682125499VU218440058SA VU218440058SA 840682125499VU218450002SA VU218450002SA 840682125499VU218450016SA VU218450016SA 840682125499VU218450024SA VU218450024SA 840682125499VU218450026SA VU218450026SA 840682125499VU218450027SA VU218450027SA 840682125499VU218500007SA VU218500007SA 840682125499VU218500022SA VU218500022SA 840682125499VU218440017SA VU218440017SA 840682125499VU219040003SA VU219040003SA 840682125499VU219040007SA VU219040007SA 840682125499VU219040012SA VU219040012SA 840682125499VU219070011SA VU219070011SA 840682125499VU219070014SA VU219070014SA 840682125499VU219070017SA VU219070017SA 840682125499VU219070020SA VU219070020SA 840682125499VU219040010SA VU219040010SA 840682125499VU219180038SA VU219180038SA 840682125499VU219120006SA VU219120006SA 840682125499VU218190016SA VU218190016SA 840682125499VU218210018SA VU218210018SA 840682125499VU218220006SA VU218220006SA 840682125499VU218220015SA VU218220015SA 840682125499VU218220017SA VU218220017SA 840682125499VU219100084SA VU219100084SA 840682125499VU218460003SA VU218460003SA 840682125499VU218220011SA VU218220011SA 840682125499VU218240009SA VU218240009SA 840682125499VU218200034SA VU218200034SA 840682125499VU218210012SA VU218210012SA 840682125499VU218240007SA VU218240007SA 840682125499VU218210015SA VU218210015SA 840682125499VU218220018SA VU218220018SA 840682125499VU218240002SA VU218240002SA 840682125499VU218200033SA VU218200033SA 840682125499VU218440052SA VU218440052SA 840682125499VU218440028SA VU218440028SA 840682125499VU218440034SA VU218440034SA 840682125499VU219120029SA VU219120029SA 840682125499VU219080001SA VU219080001SA 840682125499VU219120033SA VU219120033SA 840682125499VU219120031SA VU219120031SA 840682125499VU218430027SA VU218430027SA 840682125499VU218430041SA VU218430041SA 840682125499VU218430049SA VU218430049SA 840682125499VU218500012SA VU218500012SA 840682125499VU218430024SA VU218430024SA 840682125499VU219120022SA VU219120022SA 840682125499VU219120024SA VU219120024SA 840682125499VU219120013SA VU219120013SA 840682125499VU219120028SA VU219120028SA 840682125499VU219120034SA VU219120034SA 840682125499VU219120037SA VU219120037SA 840682125499VU219120038SA VU219120038SA 840682125499VU219120039SA VU219120039SA 840682125499VU219120047SA VU219120047SA 840682125499VU218500003SA VU218500003SA 840682125499VU219120026SA VU219120026SA 840682125499VU219120030SA VU219120030SA 840682125499VU219120041SA VU219120041SA 840682125499VU219120032SA VU219120032SA 840682125499VU219120059SA VU219120059SA 840682125499VU218440005SA VU218440005SA 840682125499VU218450018SA VU218450018SA 840682125499VU218490013SA VU218490013SA 840682125499VU218500011SA VU218500011SA 840682125499VU218500018SA VU218500018SA 840682125499VU219120017SA VU219120017SA 840682125499VU218150005SA VU218150005SA 840682125499VU218160015SA VU218160015SA 840682125499VU218190010SA VU218190010SA 840682125499VU218200006SA VU218200006SA 840682125499VU218200012SA VU218200012SA 840682125499VU218200013SA VU218200013SA 840682125499VU218200018SA VU218200018SA 840682125499VU218200019SA VU218200019SA 840682125499VU218200020SA VU218200020SA 840682125499VU218200024SA VU218200024SA 840682125499VU218210001SA VU218210001SA 840682125499VU218210006SA VU218210006SA 840682125499VU218210007SA VU218210007SA 840682125499VU218440042SA VU218440042SA 840682125499VU218430008SA VU218430008SA 840682125499VU219120027SA VU219120027SA 840682125499VU218440041SA VU218440041SA 840682125499VU217420006SA VU217420006SA 840682125499VU218450032SA VU218450032SA 840682125499VU218450043SA VU218450043SA 840682125499VU218500009SA VU218500009SA 840682125499VU219180034SA VU219180034SA 840682125499VU219190017SA VU219190017SA 840682125499VU219190022SA VU219190022SA 840682125499VU219190023SA VU219190023SA 840682125499VU219190025SA VU219190025SA 840682125499VU219190033SA VU219190033SA 840682125499VU218450022SA VU218450022SA 840682125499VU218430055SA VU218430055SA 840682125499VU218440004SA VU218440004SA 840682125499VU219130053SA VU219130053SA 840682125499VU218450028SA VU218450028SA 840682125499VU218430045SA VU218430045SA 840682125499VU219130010SA VU219130010SA 840682125499VU218430048SA VU218430048SA 840682125499VU218440008SA VU218440008SA 840682125499VU218440025SA VU218440025SA 840682125499VU219100058SA VU219100058SA 840682125499VU218210011SA VU218210011SA 840682125499VU218160009SA VU218160009SA 840682125499VU218160012SA VU218160012SA 840682125499VU218190017SA VU218190017SA 840682125499VU218200032SA VU218200032SA 840682125499VU218210026SA VU218210026SA 840682125499VU218170002SA VU218170002SA 840682125499VU218170022SA VU218170022SA 840682125499VU218200003SA VU218200003SA 840682125499VU218200029SA VU218200029SA 840682125499VU218200030SA VU218200030SA 840682125499VU218200031SA VU218200031SA 840682125499VU218440022SA VU218440022SA 840682125499VU219140019SA VU219140019SA 840682125499VU219140023SA VU219140023SA 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE 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
Action The 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 Commerce 369 units
Distribution Worldwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DQK and Original Applicant = GE Medical Systems Information Technologies, Inc.
-
-