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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, CardiacVX CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d)

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 Class 2 Recall
GE Healthcare, CardiacVX CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d)
see related information
Date Posted April 25, 2014
Recall Status1 Terminated on May 29, 2014
Recall Number Z-1511-2014
Recall Event ID 68032
Premarket Notification
510(K) Number
K121762 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
Code Information FMI# 60857 & Descr: CARDIAC VX Mfg Lot or Serial # System ID 00000D13194001 0000AP12171002 00000L0240862D 604682AWW4 00000287171GE3 00000322015GE9 00000287170GE5 506648AW1 00000328735GE6 00000281269GE1 604875AW1 00000LA714FC0A 562225MR2A 00000287169GE7 PASSMR1AW 00000Y13168001 M1102608 00000M13099001 RE1046AW01 00000P13074002 M4189445 00000S13081001 M4189445 00000L02687172 M2322216 00000L0240825E M2322233 00000L3A2D12BA M2322241 0000AN12171001 M155485707 0000AP12178001 M40345204 00000R13178002 M178710405 00000T13185001 M2426003 00000L13184001 M1248303 00000H13032001 A4463335 00000N13172001 M4482629 00000L13197001 00000N13030001 I9237520 00000M12341002 0000AN12171002 M2844538 0000AM12178005 C2195283 00000X12340001 C2195282 0000AM12178001 M2322247 00000M12341001 M2322247 0000AP12290001 X59655524 00000B12299001 X59655525 00000N13112001 M2148251 0000AA12213001 M4181459 0000AR12310001 M4166643 0000AD12321001 M9481854 00000R12325001 M9481855 00000M13135001 00000L020E0B14 A54013104 00000L3A3E5D1C A5624137 00000L3A5D9820 A5624137 00000H13071001 A5164528 00000LA71385A1 A5164527 0000AM12178002 A5624134 0000AA13107002 RL6035 00000P13010001 PZ0383 00000T13158001 PM0032 00000L3AB045C6 PM0278 00000X13200001 0000AM12178004 RL6025 00000V13009001 RL6059 0000AM12178003 RL6043 00000G12362001 JW0128 0000AM12178006 PMW087 0000ZA12135001 RL6009 0000AR12310002 RL6123 00000E12356001 PY0207 00000U13057001 RL6092 00000L13014001 RL6111 00000M13024001 RL6071 00000P13004001 RLW118 00000G13038001 RL6088 00000P13074001 RL6096 00000Q13092001 00000H13032002 0850270409AW1 0000AN12171003 0850270411AW1 0000AP12178002 KW1112AW03 0000AN12312001 0920499069 00000328736GE4 00000H13032003 PL1735AW08 00000L3A2CA72F PL1735AW01 00000LA71BD437 600042AW11 00000L3A2D1359 PL1751AW02 00000R12328001 PL2902AW01 00000Q13102001 PL1050AW02 00000N13022001 00000T13043001 SA1051AW03 0000AE13108001 0000AA13113001 00000R13178001 00000Z13190001 0000AF13098001 SA1255AW02 00000R13029001 00000L8B19A930 NP739729 00000V13009002 NP413434 0000AN12292001 NEV13614 0000AA13107001 O009AW11 00000A13192001 00000L026EA92D 849010AW02 00000L3A482932 266150AW04 00000L3A70D09C 120810AW02 00000LA70A3DDF 788000AW02 00000L3AB6762A 00440ADW18 00000L3AB048FE 00440ADW15 00000LA70E6008 00327ADW03 00000L13050001 00133ADW02 0000AN12171004 00249ADW01 00000Q13092002 00000LA716AE5C 317338AW5
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact Local Service Representative
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an Urgent Medical Device Correction" letter dated August 21,2013, to all affected consignees. The letter was addressed to Hospital Administrators /Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers were instructed until the issue is corrected on their system with the affected CardiacVX or CardiacVX Flow software for phase-contrast protocols customers use the fast CINE phase-contrast sequence with the magnitude weighting user CV option disabled. For directions on how to update user CV, please refer to the MR operator manual. If customers choose to perform imaging using magnitude weighting, do not utilize CardiacVX or CardiacVX flow for flow value calculations.with the affected product. Customers with questions were instructed to contact their local service representative. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 101 (1 US , 100 OUS)
Distribution Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS, LLC
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