Food, drugs, devices › GE Medical Systems Information Technologies Inc
Device recall: PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
FDA enforcement event 99536 is a device recall by GE Medical Systems Information Technologies Inc of Waukesha, WI, initiated 20 Jul 2026 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Medical Systems Information Technologies Inc has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems Information Technologies Inc, Waukesha, WI.
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."
Distribution
"US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3036-2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | 23 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3037-2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | 4 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3038-2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | 15 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3039-2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 | 0 | Class II | Ongoing | 2 Sep 2026 |
Context
Other enforcement events for GE Medical Systems Information Technologies Inc
All 12 events for GE Medical Systems Information Technologies Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.