GE Centricity Viewer 7.0 may expose login credentials on workstations
GE Medical Systems is recalling Centricity Universal Viewer software versions 7.0 through 7.0 SP2.0.1 because user login credentials may be exposed on the local client workstation.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states an unauthorised individual could affect system availability or manipulate medical imaging data, and no injuries are stated.
Plain-English summary
GE Medical Systems, LLC is recalling Centricity Universal Viewer software versions 7.0 through 7.0 SP2.0.1, a device that displays medical images including mammograms and data from various imaging sources, across 19 model numbers. About 1,568 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorised individual to potentially impact system availability and/or manipulate data.
Affected versions are listed by UDI number in the FDA enforcement record.
Facilities can identify affected installations by the software version above, and may contact GE Medical Systems, LLC for further information.
The recalled product
- Product
- Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030…
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 1,568
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, LLC 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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