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Gus Iversen, Editor in Chief | March 20, 2026
The FDA has classified a correction involving certain versions of GE HealthCare’s Centricity Universal Viewer as a Class II recall after the company identified a cybersecurity flaw that could expose user login credentials on local client workstations, according to the agency’s recall database.
The affected product is Centricity Universal Viewer software versions 7.0 through 7.0 SP2.0.1, an image viewing platform used to display medical images, including mammograms, and related data from multiple imaging sources. The recall is linked to 510(k) clearance K182419 and is listed under recall number Z-1569-2026 and event ID 98428, FDA records show.
The recall was initiated by the firm on Jan. 30, 2026, and posted by the FDA on March 16, 2026. The agency said the action remains open and classified. GE Medical Systems, LLC, based in Waukesha, Wisconsin, reported that the issue stems from software design.
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According to the recall notice, exposed credentials could allow an unauthorized individual to affect system availability or manipulate data. The company said 1,568 units are in commerce, with distribution listed as worldwide and throughout the U.S.
In a customer letter dated Jan. 30, GE HealthCare told users they could continue using the device while awaiting correction if they follow mitigation steps. Those steps include ensuring workstations have security controls in place as described in product manuals and using Active Directory or LDAP-based network account authentication for user management where possible.
"Patient safety is our top priority," a GE HealthCare spokesperson told HCB News. "There have been no reports of unauthorized access to patient data as a result of this potential issue. Direct physical access to the workstation is necessary to exploit this potential vulnerability.”
Facilities that cannot implement network account authentication were directed to contact GE HealthCare Service for temporary mitigation measures. Customers were also told to notify relevant users at their facilities, retain the safety notice for their records and return an acknowledgment form.
GE HealthCare said it plans to correct all affected products at no cost. Customers with questions were directed to contact GE HealthCare Service at 800-437-1171.
