FDA-Device2024-07-17Class II
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
Pivotal Health Solutions, Inc.
Hazard
This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.
Sold states
Distributed to CA, FL, TX, ID, GA, and TN
Affected count
32 tables
Manufactured in
3003 9th Ave Sw, N/A, Watertown, SD, United States
Products
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2024Don't want to check this manually?
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