Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x an
Summary
The FDA issued a Class II for Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon by Hermes Medical Solutions AB. Reason: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study..
Details
Source
Device Recall
External ID
Z-0678-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Lot/Code Info: 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
Quantity Affected: 778 systems
Reason for Recall
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-31
Company
Stockholm
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hermes Medical Solutions AB has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hermes Medical Solutions AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hermes Medical Solutions AB have FDA actions?
Hermes Medical Solutions AB has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0678-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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