Recall Z-3038-2026
GE Medical Systems Information Technologies Inc · initiated July 20, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-3038-2026
- Initiated
- July 20, 2026
- Posted by FDA
- August 27, 2026
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 15 units
- Distribution
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Recalling firm
- GE Medical Systems Information Technologies Inc, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3036-2026 Class II | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | 07/20/2026Open, Classified |
| Z-3037-2026 Class II | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | 07/20/2026Open, Classified |
| Z-3039-2026 Class II | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | 07/20/2026Open, Classified |