Reported Jul 17, 2024 · Ongoing
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable…
Pivotal Health Solutions, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pivotal Health Solutions, Inc. · 3003 9th Ave Sw · Watertown, SD · 57201-8014
Is this the product you have?
- Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published — 00850008449826UDI-DI 00850008449826 E9011— — Serial Numbers: WTN-DOC03132457209 WTN-DOC-3132457210, WTN-DOC03132457235, WTN-DOC03132457237, WTN-DOC03132457238, WTN-DOC03132457239 Expanded Recall serial numbers: WTN-DOC04262458492, WTN-DOC04262458490, WTN-DOC04262458487, WTN-DOC04262458488, WTN-DOC04262458489, WTN-DOC0332457239, WTN-DOC04082457899, WTN-DOC04262458484, WTN-DOC03132457238, WTN-DOC03132457237, WTN-DOC03132457210, WTN-DOC04082457897, WTN-DOC04082457898, WTN-DOC03132457201, WTN-DOC04192458307, WTN-DOC04082457896, WTN-DOC03132457209, WTN-DOC03132457235, WTN-DOC04262458496, WTN-DOC03132457240, WTN-DOC03132457241, WTN-DOC04082457882, WTN-DOC04172458185, WTN-DOC04082457893, WTN-DOC04082457894, WTN-DOC04082457895 - Amount recalled
- 32 tables
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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