CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Portrait Compute And Core Services V1.2 recalled by GE Medical Systems
GE Medical Systems Information Technologies is recalling Portrait Compute And Core Services V1.2, distributed in Michigan, New York. The recall was initiated on 20 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3037-2026
- FDA event ID
- 99536
- Recalling firm
- GE Medical Systems Information Technologies, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2026
- FDA classified
- 27 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2026 | Recall initiated by company | |
| 27 Aug 2026 | Classified by FDA | +38 days |
| 2 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Where it was distributed
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN 00198953056752, Serial Numbers: SWT25510001TA, SWT26110010TA, SWT26070001TA, SWT26120008TA.
Where was it sold?
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99536This product is part of a recall event; the main page for the event is Portrait Core Services recalled by GE Medical Systems.
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