GE Medical Systems Information Technologies Inc: PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

Is my product affected?

PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

• UPC 00195278679284

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 V1.1 (GTIN 00195278679284) due to a software issue affecting patient monitoring systems. The problem may cause loss of patient monitoring at the Hub and Central Viewer, and all alarm settings could reset to factory defaults following an update, meaning alarms would no longer follow the custom settings previously configured for individual patients or care areas. A total of 23 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 affected units can be identified by the serial numbers listed in the recall notice (SWT25250001TA through SWT31240012TA). The source document does not specify a remedy or corrective action for affected consumers.

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: 23 units Lot/code info: GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.

Source

Official record: FDA (Device enforcement) ↗

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

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