GE Medical Systems Information Technologies Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →