GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) pr

FDA device recall Z-2203-2012 · posted 2012-08-13 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 23, 2012 to consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the affected product details, safety issue, safety instructions and product correction. For more information on this topic, contact a GE Application Specialist or your GE Field Service representative. For questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

1055

Distribution

Worldwide Distribution - US (nationwide) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA,

Date initiated

2012-05-24

Date posted

2012-08-13

Date terminated

2012-12-11

Location

Waukesha, WI

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