CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report
TxRx Knee 15 Coil 5T QED recalled by Quality Electrodynamics
Quality Electrodynamics is recalling TxRx Knee 15 Coil 5T 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
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-0036-2020
- 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 Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
Where it was distributed
Worldwide distribution - US in the states: NC OUS: Germany
Questions about this recall
Is TxRx Knee 15 Coil 5T QED recalled?
Yes. Quality Electrodynamics recalled TxRx Knee 15 Coil 5T QED on 20 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0036-2020.
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 # 1694 1841 1887 1933 1998 3195 3291 3292 3293 3294 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 3310 3311 3312 3313 3314 3315 3316 3317 3318 ¿1137 ¿1361 ¿1378 ¿1628 ¿2447
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 |
|---|---|---|---|---|---|
| Device | CLASS II | TxRx 15CH Knee Coil 5T QED recalled by Quality Electrodynamics | Quality Electrodynamics | Other | NC |
| Device | CLASS II | TxRx 15CH Knee Coil 5T QED recalled by Quality Electrodynamics | Quality Electrodynamics | Other | NC |
| Device | CLASS II | TxRx 15Ch Knee Coil 3T QED recalled by Quality Electrodynamics | Quality Electrodynamics | Other | NC |
| Device | CLASS II | TxRx 15CH Knee Coil 3T QED recalled by Quality Electrodynamics | Quality Electrodynamics | Other | NC |
| Device | CLASS II | TxRx CP Extremity Coil 3T QED recalled by Quality Electrodynamics | Quality Electrodynamics | Other | NC |
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |