Z-0031-2020Class II

TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460

Name: Z-0031-2020 TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Creator: Quality Electrodynamics LLC
Published: 2019-08-20
License: https://open.fda.gov/license/

Quality Electrodynamics / initiated 2019-08-20 / Terminated / root cause: manufacturing process

FDA source

Quality Electrodynamics LLC began a recall of TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 on 2019-08-20. FDA classified it as Class II and gives the reason as "Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0031-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-20
Posted: 2019-10-03
Terminated: 2020-05-26
Recalling firm: Quality Electrodynamics
Product: TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Root cause tag: manufacturing process
FDA 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 in commerce: 2 units
Distribution: Worldwide distribution - US in the states: NC OUS: Germany
Product codes and lots: Serial # 1459 1460

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0031-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0031-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0032-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0033-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0034-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0035-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0036-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03
Z-0037-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-03

Product code MOS

K082636Class IITxrx 15Ch Knee Coil (1.5T and 3T), Txrx Cp Extremity Coil 3TQuality Electrodynamics / cleared 2008-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)