GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1910-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

Product Classification:

Class II

Date Initiated: May 16, 2019

Date Posted: July 10, 2019

Recall Number: Z-1910-2019

Event ID: 82998

Reason for Recall:

There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

Status: Terminated

Product Quantity: 145 (87 US 103 OUS)

Code Information:

UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated