Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential structural or material defects in medical devices.
Plain-English summary
Quality Electrodynamics LLC is recalling three units of the TxRx 15CH Knee Coil 1.5T (QED part number Q7000016, Siemens Model # 10185453). The recall is being conducted because unintended ferrous material may be present within the pushbutton assembly of the device.
The affected units were distributed worldwide, including in the United States (North Carolina) and Germany. The specific serial numbers for the recalled units are 1471, 2106, and 1991.
Consumers and healthcare facilities should stop using the affected coils and contact Quality Electrodynamics LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coil
- Affected units
- 3
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)
- Serial # 1471 2106 1991
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 →- 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 3 Siemens Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
- SevereQuality Electrodynamics Recalls Siemens Knee and Extremity MRI Coils
FDA (Devices) · 2019-10-09
- HighQuality Electrodynamics Recalls Two Siemens Knee Coils Due to Ferrous Material
FDA (Devices) · 2019-10-09
Same hazard · ferrous material
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
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