Z-2878-2026 Class II Ongoing
FDA device recall Z-2878-2026 was initiated by GE Medical Systems Information Technologies Inc on July 10, 2026 and is designated Class II. 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 Hea… The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- July 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
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).
Distribution Pattern
Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
Code Information
GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.