FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies Inc: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
- Recall number
- Z-2878-2026
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
- Status
- Open, Classified
- Initiated
- 2026-07-10
- Posted
- 2026-08-04
- Terminated
- not on file
- Reason
- Portrait Core Services Software version V1.2.0 Security Vulnerability
- Root cause
- Software design
- Action
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 7/10/2026 via traceable means. The notice explained the safety issue, and requested the following: "Actions to be taken by Customer/User You can continue to use Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.2.0, pending GE HealthCare correction. If you need help to identify if your Portrait Mobile Monitoring Solution has Portrait Core Services SW 1.2.0, contact GE HealthCare Service. Ensure that your facility follows all hospital networking and cybersecurity policies and procedures along with the security considerations outlined in the GE HealthCare Portrait Mobile Monitoring Solution Privacy and Security Manual p/n 5970026. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or a local Service Representative.
- Quantity
- 11 units
- Distribution
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Lot, serial or model codes
- GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
- 510(k) numbers
- ["K234130"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3001570235
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28