Hitachi Oasis MRI Coil Extension Cable Recalled for Overheating Burn Hazard
Hitachi Medical Systems America Inc is recalling 173 Oasis Coil Extension Cables used with MRI systems because they may overheat and cause burns.
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 risk-of-harm product (burn hazard) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 173 units of the Oasis Coil Extension Cable, an accessory used with the Hitachi Oasis MRI System. The recall was initiated after the firm received a complaint stating that the cable accessory would overheat and pose a burn hazard if touched.
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in Mexico. The specific serial numbers involved in this recall are M001 to M108, M110 to M175, M951, and M952.
Consumers and healthcare facilities should stop using the affected cables immediately and contact Hitachi Medical Systems America Inc for further instructions on the removal action.
The recalled product
- Product
- Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The O
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI Accessories
- Hazard
- Affected units
- 173
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 (3)
- Serial #'s: M001to M108
- M110 to M175
- M951 & M952.
Distribution
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