Change Healthcare Stratus Imaging PACS 1.4 and Stratus recall
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Why was Change Healthcare Stratus Imaging PACS 1.4 and Stratus recalled?
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Version 1.4, UDI (01)17540262160093(10)010400
- Product
- Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Quantity
- 454
- Distribution
- US Nationwide distribution. There was no military/government distribution.
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)