Quality Electrodynamics Recalls 17 Non-Functional MRI Knee Coils
Quality Electrodynamics LLC is recalling 17 TxRx Knee 15 Coil 3T units because the coil identification code is incorrect, rendering the devices non-functional.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a non-functional device due to an incorrect identification code, which is a documentation or functional defect that does not pose a risk of adverse health consequences or injury.
Plain-English summary
Quality Electrodynamics LLC is recalling 17 units of the TxRx Knee 15 Coil 3T. These medical devices are used in conjunction with magnetic resonance scanners to produce diagnostic images of the knee for interpretation by trained physicians.
The recall was initiated after the firm was reported on July 27, 2012, that the Siemens 3T 15ch Knee Coil was not functional due to an incorrect coil identification code. The affected units are identified by QED part numbers Q7000057/QED000057/QSV000057 and Siemens part numbers 10606829 / 10606614, with serial numbers 1002-1012, 1016-1020, and 1022.
The devices were distributed worldwide, specifically in Tennessee, USA, and Germany. Users should stop using the affected coils and contact the recalling firm for instructions on resolution.
The recalled product
- Product
- TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
- Manufacturer
- Quality Electrodynamics LLC
- Category
- Medical Device — MRI Coil
- Affected units
- 17
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 (2)
- 1016-1020
- and 1022.
Distribution
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