Quality Electrodynamics Recalls MRI Extremity Coils Due to Ferrous Material
Quality Electrodynamics LLC is recalling five Siemens MRI extremity 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 in an MRI environment) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Quality Electrodynamics LLC is recalling five units of the TxRx CP Extremity Coil 3T (QED part number Q7000019, Siemens Model # 10185464). The recall is due to the potential presence of unintended ferrous material within the pushbutton assembly of the device.
The affected units have serial numbers 1308, 1309, 1310, 1311, and 1313. These coils were distributed worldwide, including in the United States (North Carolina) and Germany. The source text does not specify the number of patients affected or report any injuries.
Healthcare facilities and users should stop using the affected coils and contact Quality Electrodynamics LLC for instructions on how to proceed.
The recalled product
- Product
- TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coil
- 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 # 1308 1309 1310 1311 1313
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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