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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2013-09-19Z-0270-2014Class IITerminatedGE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correcDistribution: Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .1458 (336 US, 1122 OUS)clearance family
Regulatory clearances
  • 510(k)K110834Substantially equivalent (SESE) · 2011-04-26clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2022-09-29NAINo action indicatedGE Medical Systems, LLC0
2018-06-14VAIVoluntary action indicatedGE Medical Systems, LLC0
2016-10-11NAINo action indicatedGE MEDICAL SYSTEMS, LLC0
2014-11-10NAINo action indicatedGE Medical Systems, LLC0
2014-02-28VAIVoluntary action indicatedGE Medical Systems, LLC1
2013-06-17VAIVoluntary action indicatedGE Medical Systems, LLC1
2012-10-11NAINo action indicatedGE Medical Systems, LLC0
2012-03-02VAIVoluntary action indicatedGE Medical Systems, LLC7
2011-01-11VAIVoluntary action indicatedGE Medical Systems, LLC3
2010-04-26NAINo action indicatedGE Medical Systems, LLC0
2010-01-29NAINo action indicatedGE Medical Systems, LLC0
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