GE Healthcare Recalls Innova Fluoroscopic Systems Due to Relay Failure
GE Healthcare is recalling 713 Innova fluoroscopic systems because a relay failure in the power distribution box can cause sudden loss of imaging modes without warning.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria for FDA Class II recalls without reported injuries.
Plain-English summary
GE Healthcare, LLC is recalling 713 units of the Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ, Innova 3100, and Innova 4100 fluoroscopic systems. These devices are used to generate fluoroscopic images of human anatomy for diagnostic and interventional procedures.
The recall is due to a potential relay failure in the power distribution box (PDB). This failure can result in a nonrecoverable loss of imaging modes without advance warning during a fluoroscopic examination. Although no injuries have been reported to date, the loss of imaging functionality poses a risk of complications during procedures.
The affected units were distributed worldwide, including nationwide in the United States and in various countries in the Americas, Asia, and Europe. Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice and contact GE Healthcare for corrective action.
The recalled product
- Product
- GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 713
Distribution
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