GE Healthcare Portrait Core Services SW V 1.2.0 Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
GE Medical Systems Information Technologies Inc is recalling 11 units of its Portrait Core Services SW V 1.2.0 patient monitoring system due to a software vulnerability.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
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 Products Are Affected
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. 11 units distributed worldwide, including US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. GTIN 00198953056752. Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C. Recall number Z-2878-2026.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter for addressing the software vulnerability.
Why This Matters
The vulnerability could lead to loss of patient monitoring, missed alarms, or unauthorized access to protected health information.
Source
FDA recall Z-2878-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,045 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.