Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Summary
The FDA issued a Class II for Millenium Myosight; dual-head nuclear medicine gamma camera designed specificall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or reloca.
Details
Source
Device Recall
External ID
Z-0298-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product Description
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Lot/Code Info: all serial numbers in distribution
Quantity Affected: 82 units
Reason for Recall
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-12
Company
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 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 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 (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING have FDA actions?
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0298-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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