Quality Electrodynamics Recalls Two Siemens Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling two Siemens 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 3/5 (High).
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 potential hazard (ferrous material) that could pose a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Quality Electrodynamics LLC is recalling two units of the TxRx 15Ch Knee Coil 3T (QED part number Q7000008, Siemens Model # 10185460). The recall is being conducted because unintended ferrous material may be present within the pushbutton assembly of the device.
The affected units are identified by serial numbers 1459 and 1460. These devices were distributed worldwide, including in North Carolina, United States, and Germany. The recall is classified as Class II by the U.S. Food and Drug Administration.
Hospitals and medical facilities should stop using the affected coils and contact Quality Electrodynamics LLC for further instructions regarding the recall.
The recalled product
- Product
- TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coil
- Hazard
- Affected units
- 2
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 # 1459 1460
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
- SevereQuality Electrodynamics Recalls 3 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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