Recall archive / FDA device enforcement
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 — FDA record Z-3038-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 20, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Quantity
- 15 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3038-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 2, 2026
- Recall initiation date
- Jul 20, 2026
- Center classification date
- Aug 27, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.