GE Healthcare CT Systems Display Incorrect Radiation Doses During Certain Exams
GE Healthcare's Revolution CT systems may display accumulated radiation doses up to 100 times higher than the actual dose delivered during certain interventional imaging procedures. The displayed value is incorrect, but the actual dose patients receive is accurate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a risk-of-harm product (CT imaging system) where an incorrect dose display could influence clinical decision-making. No injuries or hospitalizations have been reported, and the actual radiation dose delivered remains accurate.
Plain-English summary
GE Healthcare is recalling certain Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex edition computed tomography systems. A total of 105 units are affected, distributed worldwide and throughout the US.
The issue: During interventional imaging exams when the SmartStep option is used, if the table height is adjusted after the exam begins, the accumulated dose display may show a value significantly higher than the actual radiation dose delivered. The displayed value may overstate the actual dose by up to 100 times.
Why it matters: While the actual radiation dose received by patients is correct, the incorrect display could mislead clinical staff about radiation exposure levels, potentially affecting clinical decision-making or patient communication regarding radiation exposure.
Healthcare facilities using these systems should be aware of this display discrepancy in their imaging procedures. The actual radiation dose administered to patients remains accurate despite the display error.
The recalled product
- Product
- Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Revolution CT
- Revolution CT ES
- Revolution Apex
- Revolution CT with Apex edition
Distribution
Distributed nationwide across the United States.
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