Device recall: T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices…
Class II FDA enforcement event 80165. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur.
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
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL started this device recall on 2 Apr 2018. The firm address in the FDA record is in Milwaukee, WI. FDA put the recall in Class II. FDA event 80165 has 1 product record. The first FDA enforcement report date is 25 Jul 2018. The record gives the status Terminated, with the termination date 30 Apr 2024.
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 Nationwide in the states of AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. International distribution to…
Recalling firm
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Milwaukee, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2467-2018 | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise… | 3,721 devices total | Class II | Terminated | 25 Jul 2018 |
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 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 1Median of the firm: 3
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Mar 2018 | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound eval | Device | Class II | 8 |
| 16 Mar 2018 | GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD ( | Device | Class II | 3 |
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL: all 3 events
Official channels
- FDA enforcement report Z-2467-2018The 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.
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Cite this page
Recall Register. FDA enforcement event 80165. https://recallregister.com/fda/ii/80165/. 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 Nationwide in the states of AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. International distribution to…
- What quantity of product is in FDA event 80165?
- The FDA record gives this quantity:
3,721 devices total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.