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 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 is classified as FDA Class II and involves a risk-of-harm product (ferrous material in an MRI environment) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Quality Electrodynamics LLC is recalling three units of the TxRx 15CH Knee Coil 1.5T (QED part number Q7000050, Siemens Model # 10606524). The recall is being conducted because unintended ferrous material may be present within the pushbutton assembly of the device.
The affected units have serial numbers 1433, 1702, and 1440. These devices were distributed worldwide, including in North Carolina, USA, 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 instructions on how to proceed. Consumers should not use these devices if they are in their possession.
The recalled product
- Product
- TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coils
- 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 # 1433 1702 1440
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
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- HighQuality Electrodynamics Recalls 15CH Knee Coils Due to Ferrous Material
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