GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advant

FDA device recall Z-1511-2014 · posted 2014-04-25 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

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, U

Date initiated

2014-04-07

Date posted

2014-04-25

Date terminated

2014-05-29

Location

Waukesha, WI

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