DeviceSignal · Recall classified
GE Medical Systems Information Technologies Inc
FDA classified a device recall on 2026-08-27 · Class II · Z-3036-2026
EventRecall classified
Effective2026-08-27
ClassificationClass II
On 2026-08-27 the FDA classified a device recall from GE Medical Systems Information Technologies Inc as Class II. Product: PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209. Recall Z-3036-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3036-2026
- Classification
- Class II
- Classified on
- 2026-08-27
- Initiated on
- 2026-07-20
- Firm
- GE Medical Systems Information Technologies Inc
- 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.
- Product
- PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3036-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
c8410a1cca4bb19e6db6f6ea642945421bc7108578cd07a65160256ad6769837- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)