Radiological imaging system may mismatch patient records
GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with a data integrity defect creating risk of patient harm through mismatched medical records. No illnesses or injuries reported; the hazard is substantive but harm is theoretical.
Plain-English summary
GE Healthcare is recalling the Centricity PACS-IW Radiological Image Processing System due to a defect where patient information from two different patients can be mismatched when correcting patient or study information.
The issue affects 153 units of the Centricity PACS-IW system with worldwide distribution. This medical imaging system is used to manage and process radiological images in healthcare settings.
Patient information mismatches could result in incorrect medical records being associated with the wrong patient, potentially leading to diagnostic or treatment errors. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
- Manufacturer
- GE Healthcare
- Affected units
- 153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) 2041037-001
- No UDI/DI
- Product ID Numbers: 4443-1-Centricity PACS-IW-00558167
- b) 2042988-001
- Product ID Numbers: 707509-Centricity PACS-IW-01452391
- 613493-Centricity PACS-IW-02292544
- SiteID-Centricity PACS-IW-01572187
- c) 2049587-009
- Product ID Numbers: 1402-7-Centricity PACS-IW-18957305
- 1402-7-Centricity PACS-IW-19265438
- 1402-7-Centricity PACS-IW-18166109
- 1402-7-Centricity PACS-IW-18166110
- 1402-2-Centricity PACS-IW-18984905
- 1402-2-Centricity PACS-IW-18985934
- 1402-2-Centricity PACS-IW-19031647
- 1402-1-Centricity PACS-IW-17192703
- 1402-1-Centricity PACS-IW-17192704
- 1402-1-Centricity PACS-IW-00558291
- 4276-1-Centricity PACS-IW-00558274
- 12974-1-Centricity PACS-IW-00558300
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · GE Healthcare
See all →- HighGE radiology viewer may show patient information not matching displayed images
FDA (Devices) · 2026-03-11
- HighGE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access
FDA (Devices) · 2025-04-09
- HighGE Healthcare Cardiology CA1000 Security Vulnerability Could Allow Patient Data Access
FDA (Devices) · 2025-04-09
- HighGE Healthcare Centricity Radiology RA600 and related imaging systems login vulnerability
FDA (Devices) · 2025-04-09
- HighGE Healthcare Medical Imaging Software Vulnerability Allows Unauthorized System Access
FDA (Devices) · 2025-04-09
Same hazard · patient data mismatch
See all →- HighGE Healthcare Versana Ultrasound Systems display incorrect fetal weight data
FDA (Devices) · 2025-07-02
- HighHillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall
FDA (Devices) · 2024-11-13
- HighCardiac stress testing system may assign duplicate exam identifiers to patients
FDA (Devices) · 2024-11-13
- HighElectrocardiograph System May Assign Duplicate Identifiers to Patient Exams
FDA (Devices) · 2024-11-13
- HighElectrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers
FDA (Devices) · 2024-11-13