PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
GE Medical Systems Information Technologies Inc · 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 fol…
Open FDA's page for this record- Cfres ID
- 221791
- Product res number
- Z-3038-2026
- Event date initiated
- 2026-07-20
- Event date posted
- 2026-08-27
- Recall status
- Open, Classified
- Res event number
- 99536
- Product code
- MWI
- Product description
- PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- Firm FEI number
- 3001570235
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Address 1
- 3114 N Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal code
- 53188-1615
- Additional info contact
- GE HealthCare Service 800-437-1171
- Root cause description
- Device Design
- Product quantity
- 15 units
- Distribution pattern
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Code info
GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.
- 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.
- Action
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 7/20/2026 by letter delivered using traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User You can continue to use your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2. Please ensure appropriate alternative monitoring is established for patients before a software update is started. A User Manual addendum is included with this letter that includes specific instructions related to alternative monitoring. Please place a copy of the addendum in Appendix A with the User Manual for your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system in your facility. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- K numbers
- K230626
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2300
- Device class
- 2
- K number
- K080173, K053112, K151839, K053193, K150869, K210204, K151644, K113165, K143751, K121013, K123711, K183370, K013019, K101571, K093017, K181919, K152330, K153225, K131898, K082256, K073094, K170032, K134014, K170168, K122133, K013470, K010732, K133450, K003622, K101127, K143372, K172200, K071802, K072516, K130740, K153739, K010342, K000404, K063419, K170047 +268 more
- Registration number
- 3038259592, 1316463, 3011683100, 8022257, 3007137598, 1221108, 3004091281, 3021632375, 3006606827, 3012238587, 3010097171, 3006648320, 3008977358, 3011353843, 3001570235, 3027256461, 3009673645, 3019834104, 3034603598, 3016670256, 9610105, 9680215, 3032013079, 8020045, 3004415095, 1222630, 3008787503, 1833920, 3023412068, 3007836437, 3003174284, 3035111606, 3009001657, 3033959233, 3007481893, 3013596024, 2520313, 3021219789, 3007029079, 3042175844 +136 more
- FEI number
- 3038259592, 1316463, 3011683100, 3004117725, 3004631140, 3007137598, 1221108, 3006606827, 3021632375, 1000292048, 3012238587, 3010097171, 3006648320, 3008977358, 3011353843, 3001570235, 3002807880, 3009673645, 3019834104, 3027256461, 3034603598, 3002807785, 3016670256, 3032013079, 3004415095, 3008787503, 3023412068, 3007836437, 3000957797, 3005154439, 3003174284, 3035111606, 3009001657, 3033959233, 3007481893, 3013596024, 2520313, 3021219789, 3007029079, 3042175844 +136 more