Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding
Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.
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: The recall involves a medical device with a shielding defect in an MRI environment, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Invivo Corporation is recalling 75 units of the Monitor for the Functional Imaging System for Magnetic Resonance Imaging System. The specific components involved are the Philips SensaVue DVI Adapter for computer monitors, identified by codes 9896-032-0815 (SensaVue HD) and 9896-032-0872x (SensaVue fMRI).
The recall was initiated because the adapters have insufficient shielding. This defect is associated with the use of the monitors in a Magnetic Resonance Imaging (MRI) environment.
The affected units were distributed in the United States to Alaska, Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and West Virginia. They were also distributed in Australia, Canada, France, the United Kingdom, Italy, Japan, the Netherlands, Saudi Arabia, India, and Thailand. Users should contact Invivo Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 75
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 (1)
- 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Distribution
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