Device recall
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- Recall number
- Z-3038-2026
- Event id
- 99536
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Report date
- Sep 2, 2026
- Posted
- Aug 27, 2026
- Initiated
- Jul 20, 2026
- Center classification date
- Aug 27, 2026
- Product code
- MWI
- Device type
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- 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.
- Root cause
- Device Design
- Quantity
- 15 units
- Code info
- GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.
- Distribution
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K230626
- Location
- Waukesha, WI, United States