Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun
Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.
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 risk of burn injury (hot to the touch) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 180 units of the Hitachi Oasis MRI System C-Spine Coil. The recall was initiated after a customer reported that the coil balun was hot to the touch when removing the coil from the patient table following an examination.
The affected units were distributed nationwide in the United States to various states and three government accounts, including VA Medical Centers. The specific serial numbers affected are listed in the source data, ranging from M001 to M238 with specific exclusions.
Healthcare facilities and consumers should stop using the affected C-Spine Coils immediately. Hitachi Medical Systems America Inc is the recalling firm responsible for managing this recall.
The recalled product
- Product
- Hitachi Oasis MRI System - C-Spine Coil
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI Coil
- Hazard
- Affected units
- 180
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 (20)
- M001 to M028
- M029 to M083
- M085 to M090
- M092 to M104
- M106
- M110 to M111
- M113 to M114
- M116 to M123
- M125
- M128 to M131
- M133
- M139 to M141
- M143 to M147
- M150
- M152
- M154
- M159
- M161
- M163
- M166
Distribution
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