GE Healthcare Treadmill T2100 and T2000 Power Cord Recall
GE Healthcare is recalling T2100 and T2000 treadmills due to a potential safety issue with the power cord assembly.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential safety issue with power cord assembly on a medical device, which poses a risk of harm (such as electrical shock or fire) even though specific injuries are not reported in the source text.
Plain-English summary
GE Healthcare is recalling Treadmill T2100 and Treadmill T2000 units equipped with specific power cord part numbers (408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B) and Field Replaceable Units (P/Ns 408930-001 Rev E, 408930-002 Rev C). The recall involves 13,345 units, with 5,495 distributed in the United States and 7,850 distributed outside the U.S.
The recall is issued due to a potential safety issue associated with the improper assembly of the power cords on these treadmills. The affected devices are used for exercise testing and facilitating accurate blood pressure measurements within a speed range of 0-13.5 miles per hour.
Affected units were distributed in the continental United States, including DC and Puerto Rico, as well as in numerous countries outside the U.S. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the improper assembly of the power cords.
The recalled product
- Product
- GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord…
- Manufacturer
- GE Healthcare
- Hazard
Distribution
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