Centricity PACS Foundation Centricity PACS software recall
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation…
Why was Centricity PACS Foundation Centricity PACS software recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 92 (47 US 103 OUS)
- Distribution
- 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.
- Recall date
- July 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)