Quality Electrodynamics Recalls 15CH Knee Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling five Siemens 15CH 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 safety hazard (ferrous material) where no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Quality Electrodynamics LLC is recalling five units of the TxRx 15CH Knee Coil 3T (QED part number Q7000051, Siemens Model # 10606525). The recall is due to the potential presence of unintended ferrous material within the pushbutton assembly of the device.
The affected units are identified by serial numbers 1571, 1572, 1573, 1574, and 1575. These devices were distributed worldwide, including in the United States (North Carolina) and Germany.
The source text does not specify the required actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coil
- Hazard
- Affected units
- 5
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 # 1571 1572 1573 1574 1575
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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