Hybrid Recon software on Hermes Medical Imaging Suite recall: Software Issue
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Why was Hybrid Recon software on Hermes Medical Imaging Suite recalled?
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT 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?
Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending
- Product
- Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
- Recalling firm
- Hermes Medical Solutions AB
- Quantity
- 778 systems
- Distribution
- U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.: Germany, and United Kingdoms
- Recall date
- December 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)