Device recall: TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Class II FDA enforcement event 83775. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Class II, in the words of FDA
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
Quality Electrodynamics LLC started this device recall on 20 Aug 2019. The firm address in the FDA record is in Mayfield Village, OH. FDA put the recall in Class II. FDA event 83775 has 7 product records. The first FDA enforcement report date is 9 Oct 2019. The record gives the status Terminated, with the termination date 26 May 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US in the states: NC OUS: Germany
Recalling firm
Quality Electrodynamics LLC, Mayfield Village, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0031-2020 | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 | 2 units | Class II | Terminated | 9 Oct 2019 |
| Z-0032-2020 | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 | 3 units | Class II | Terminated | 9 Oct 2019 |
| Z-0033-2020 | TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464 | 5 units | Class II | Terminated | 9 Oct 2019 |
| Z-0034-2020 | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 | 3 units | Class II | Terminated | 9 Oct 2019 |
| Z-0035-2020 | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 | 5 units | Class II | Terminated | 9 Oct 2019 |
| Z-0036-2020 | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 | 36 units | Class II | Terminated | 9 Oct 2019 |
| Z-0037-2020 | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 | 21 units | Class II | Terminated | 9 Oct 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 7
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jul 2012 | TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee t Event 62949 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0031-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83775. https://recallregister.com/fda/ii/83775/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US in the states: NC OUS: Germany
- What quantity of product is in FDA event 83775?
- The event has 7 product records. The first record gives this quantity:
2 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.