CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
GE Healthcare Portrait Core Services SW recalled by GE Medical Systems
GE Medical Systems Information Technologies is recalling GE Healthcare Portrait Core Services SW V 1.2.0, distributed nationwide in the US. The recall was initiated on 10 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-2878-2026
- FDA event ID
- 99475
- Recalling firm
- GE Medical Systems Information Technologies, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2026
- FDA classified
- 4 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 10 Jul 2026 | Recall initiated by company | |
| 4 Aug 2026 | Classified by FDA | +25 days |
| 12 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
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
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Where it was distributed
Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
Questions about this recall
Why was it recalled?
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
Which lots are affected?
GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
Where was it sold?
Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
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.
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