Z-1911-2019 Class II Terminated
FDA device recall Z-1911-2019 was initiated by GE Healthcare, LLC on May 16, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 14, 2023). Affected quantity: 92 (47 US 103 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- May 16, 2019
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 (47 US 103 OUS)
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.
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.
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.
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