Quality Electrodynamics Recalls Siemens Knee and Extremity MRI Coils
Quality Electrodynamics LLC is recalling 21 Siemens MRI coils due to potential ferrous material in the pushbutton assembly.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, and the presence of ferrous material in MRI coils poses a significant risk of injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Quality Electrodynamics LLC is recalling 21 units of the TxRx Knee 15 Coil 1.5T (QED part number Q7000057, Siemens Model # 10606829). The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-0037-2020.
The recall is due to the possibility that unintended ferrous material may be present within the pushbutton assembly of the affected Siemens Knee and Siemens Extremity Coils. The affected units were distributed worldwide, including in the United States (North Carolina) and Germany.
Healthcare facilities and users should stop using the affected coils and contact Quality Electrodynamics LLC for further instructions on the recall.
The recalled product
- Product
- TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coils
- Affected units
- 21
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
Same manufacturer · Quality Electrodynamics LLC
See all →- SevereQuality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
- HighQuality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
- HighQuality Electrodynamics Recalls MRI Extremity Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
- SevereQuality Electrodynamics Recalls MRI Knee Coils Due to Ferrous Material Risk
FDA (Devices) · 2019-10-09
- HighQuality Electrodynamics Recalls 15CH Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
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FDA (Devices) · 2026-04-08
- HighQuality Electrodynamics Recalls Two Siemens Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
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