United StatesPORTRAIT CORE SERVICES SOFTWARE V1.1 (Ref# 5700209) and related products—PORTRAIT COMPUTE AND CORE SERVICES V1.2 (Ref# 5700592), PORTRAIT CORE SERVICES SOFTWARE V1.0.5 (Ref# 5697353) and FRU PORTRAIT CORE SERVICES SW RELOAD V1.1 (Ref# 5700225)—are recalled; affected units are identified by the GTINs 00195278679284, 00198953056752, 00195278364838 (UDI‑DI 00195278679307) and the serial numbers listed in the notice. They were recalled because a software issue may cause loss of patient monitoring at the Hub and Central Viewer and may reset all alarm settings to factory defaults so they do not follow previously configured patient or care area settings.
What's being recalled
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Recalling firm: GE Medical Systems Information Technologies Inc, Waukesha, WI, United States.
How to identify it
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. GTIN 00198953056752, Serial Numbers: SWT25510001TA, SWT26110010TA, SWT26070001TA, SWT26120008TA. GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA. UDI-DI (GTIN) 00195278679307
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)