OVERLOOKED

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Class IIOngoing

GE Medical Systems Information Technologies Inc recalls 4 products

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
GE Medical Systems Information Technologies Inc
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Where
Michigan, New York
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99536…

Products (4)

  1. PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

    Codes/lots: 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.Quantity: 23 unitsRecall no. Z-3036-2026Class II

  2. PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

    Codes/lots: GTIN 00198953056752, Serial Numbers: SWT25510001TA, SWT26110010TA, SWT26070001TA, SWT26120008TA.Quantity: 4 unitsRecall no. Z-3037-2026Class II

  3. PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

    Codes/lots: GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.Quantity: 15 unitsRecall no. Z-3038-2026Class II

  4. FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

    Codes/lots: UDI-DI (GTIN) 00195278679307Quantity: 0Recall no. Z-3039-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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