FDA Medical Device Recalls (openFDA)
Quality Electrodynamics LLC: TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
- Recall number
- Z-0032-2020
- Recalling firm
- Quality Electrodynamics LLC
- Product
- TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
- Status
- Terminated
- Initiated
- 2019-08-20
- Posted
- not on file
- Terminated
- 2020-05-26
- Reason
- Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent a notification letter to their customers who that have received the affected device. Customers were instructed to. 1. Immediately examine your inventory and quarantine product subject to recall. 2. if you have further distributed this product to MRI end users, please identify your affected customers and notify them. 3. Please ensure they understand to stop use of the coil for scanning and to notify you immediately.
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US in the states: NC OUS: Germany
- Lot, serial or model codes
- Serial # 1471 2106 1991
- 510(k) numbers
- ["K082636"]
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 3007350713
- Firm city
- Mayfield Village
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28