Infinia nuclear medicine systems may show unintended radial detector motion
Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: unintended motion of a detector around a patient, which the manufacturer says may cause life-threatening injury, with no injury reported in the source.
Plain-English summary
The Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 Nuclear Medicine systems are being recalled, identified by the serial numbers listed in the recall notice. The action covers 1,822 units.
According to the manufacturer, unintended radial detector motion may occur during patient setup or during a patient scan if the system does not have the correct version of gantry software installed, and unintended detector motion may result in life-threatening injury. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Affected units
- 1,822
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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