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Recall Observatory FDA recall evidence

Device product

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Z-0023-2016

September 16, 2015

Class II

Product summary

Firm
GE Healthcare
Event
Event 72212
Status
Terminated
Classification
Class II
Quantity
921 systems are impacted.
Official record key
device-enforcement:Z-0023-2016

Official wording

Reason: Images may be missing when a system parameter MapRoute is set to a value greater than 1.

Code information: GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1

Distribution pattern: Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam¿, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Images may be missing when a system parameter MapRoute is set to a value greater than 1.