FDAFDA recall Z-2878-2026 · Aug 12, 2026
GE Medical Systems Information Technologies Inc: GE Healthcare Portrait Core Services SW V 1 recall
Recall found
Product
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
- Quantity
- 11 units
- Distribution
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Recalling firm
- GE Medical Systems Information Technologies Inc, Waukesha, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-10
Source: openFDA enforcement record Z-2878-2026 · search recall number Z-2878-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.