Quality Electrodynamics Recalls MRI Knee Coils Due to Ferrous Material Risk
Quality Electrodynamics LLC is recalling 36 Siemens MRI knee coils because unintended ferrous material may be present in the pushbutton assembly.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The presence of ferrous material in an MRI environment poses a significant risk of injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Quality Electrodynamics LLC is recalling 36 units of the TxRx Knee 15 Coil 1.5T (QED part number Q7000056, Siemens Model # 10606828). The recall was initiated because unintended ferrous material may be present within the pushbutton assembly of the affected Siemens Knee and Extremity Coils.
The affected units were distributed worldwide, including in the United States (North Carolina) and Germany. The specific serial numbers for the recalled units are listed in the agency's recall record.
Healthcare facilities and users should stop using the affected coils immediately and contact Quality Electrodynamics LLC for instructions on how to return or replace the devices.
The recalled product
- Product
- TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coils
- Affected units
- 36
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Quality Electrodynamics LLC 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.
See all 7 products in this recall →Related recalls
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