CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report

TxRx 15Ch Knee Coil 3T QED recalled by Quality Electrodynamics

Quality Electrodynamics is recalling TxRx 15Ch Knee Coil 3T QED, distributed in North Carolina. The recall was initiated on 20 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # 1459 1460

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0031-2020
FDA event ID: 83775
Recalling firm: Quality Electrodynamics, Mayfield Village, OH
Classification: Class II
Status: Terminated
Recall initiated: 20 Aug 2019
FDA classified: 3 Oct 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

20 Aug 2019	Recall initiated by company
3 Oct 2019	Classified by FDA	+44 days
9 Oct 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US in the states: NC OUS: Germany

North Carolina

Questions about this recall

Is TxRx 15Ch Knee Coil 3T QED recalled?

Yes. Quality Electrodynamics recalled TxRx 15Ch Knee Coil 3T QED on 20 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0031-2020.

Why was it recalled?

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Which lots are affected?

Serial # 1459 1460

Where was it sold?

Worldwide distribution - US in the states: NC OUS: Germany

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Quality Electrodynamics

All 8

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Device	CLASS II	TxRx Knee 15 Coil 5T QED recalled by Quality Electrodynamics	Quality Electrodynamics	Other	NC
9 Oct 2019Device	CLASS II	TxRx 15CH Knee Coil 5T QED recalled by Quality Electrodynamics	Quality Electrodynamics	Other	NC
9 Oct 2019Device	CLASS II	TxRx 15CH Knee Coil 5T QED recalled by Quality Electrodynamics	Quality Electrodynamics	Other	NC
9 Oct 2019Device	CLASS II	TxRx 15CH Knee Coil 3T QED recalled by Quality Electrodynamics	Quality Electrodynamics	Other	NC
9 Oct 2019Device	CLASS II	TxRx CP Extremity Coil 3T QED recalled by Quality Electrodynamics	Quality Electrodynamics	Other	NC

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All 3,097

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12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide