GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1911-2019)

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 PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.

Product Classification:

Class II

Date Initiated: May 16, 2019

Date Posted: July 10, 2019

Recall Number: Z-1911-2019

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: 92 (47 US 103 OUS)

Code Information:

UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9, CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5

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