- Recalling firm
- GE Medical Systems Information Technologies Inc
- 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).
- Affected products (lot / model / serial)
- GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
- Units affected
- 11 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Firm location
- Waukesha, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2878-2026
- Recall initiated
- July 10, 2026
- FDA classification date
- August 4, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99475
- Last updated on HTM Vibe
- August 18, 2026