GE Medical Systems Information Technologies Inc: PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Is my product affected?

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

• UPC 00195278364838

Check against the official notice below — it lists the full affected range.

What happened

GE Medical Systems Information Technologies Inc is recalling Portrait Core Services Software version 1.0.5 due to a software issue that may cause loss of patient monitoring at the Hub and Central Viewer. The software update may also reset all alarm settings to factory defaults, preventing the system from using alarm settings that were previously configured for individual patients or care areas. A total of 15 units were distributed to locations in Michigan and New York in the United States, as well as to Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, and the United Kingdom.

The recall involves specific serial numbers of affected devices. The source document does not specify what remedy is available to consumers or healthcare facilities affected by this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom. Quantity: 15 units Lot/code info: GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls