GE Healthcare Centricity Radiology RA600 and related imaging systems login vulnerability
GE Healthcare is recalling Centricity Radiology RA600 and related imaging systems due to a security vulnerability allowing service login credentials to be identified, potentially exposing patient data to unauthorized access.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall involving a security vulnerability that poses risk of unauthorized system access and patient data compromise. No actual unauthorized access or patient harm has been reported. The vulnerability is a genuine risk-of-harm scenario but without reported incidents, limiting the score to High per the rubric.
Plain-English summary
GE Healthcare is recalling Centricity Radiology RA600 and related medical imaging products (Centricity Universal Viewer, Centricity PACS-IW, and Centricity Cardiology CA1000) due to a security vulnerability. The vulnerability allows service login credentials to be identified by unauthorized users, which could potentially allow malicious actors to access the system and manipulate patient data.
Approximately 1,563 units have been distributed worldwide. The vulnerability affects healthcare institutions using these imaging systems.
This is a Class II recall by the FDA. Healthcare facilities with affected systems should take appropriate action to address this security vulnerability and protect patient information.
The recalled product
- Product
- GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12)…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Radiology
- Affected units
- 1,563
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)
- Model/Catalog/Code # 2022296-001
- Installed Product ID 103889-1-Centricity RA600-01461073
- UDI UDI Not Required
- System ID NDMGRA01
- Installed Product ID AH5045-Centricity RA600-00000127
- UDI UDI not required
- System ID AH5045RW01
- Installed Product ID AP0701-Centricity RA600-00000173
- System ID AP0701RW01
- Installed Product ID 50451-Centricity RA600-02351785
- System ID HCIT1169080RA600
- Installed Product ID 519926-Centricity RA600-00000672
- UDI UDI Not required
- System ID 519926RW01
- Installed Product ID A51043-Centricity RA600-00040985
- System ID A51043117
- Installed Product ID 549858-Centricity RA600-01286184
- System ID MJ1
- Installed Product ID RW602-Centricity RA600-00005819
- System ID RW60200083
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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.
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