Decompression Table Model E9011 Recalled for Structural Frame Defect
Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.
What this means for you
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: FDA Class II recall involving a structural defect on a medical device that applies physical forces. No illnesses or injuries have been reported. The theoretical risk of frame failure during treatment warrants High severity per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Pivotal Health Solutions, Inc. is recalling 32 Decompression Table Model E9011 units that have been distributed due to a manufacturing defect. The device applies cervical and lumbar decompression therapy with practitioner-adjustable treatment settings.
The recall was initiated because of potentially insufficient rework on part E7130-B in the lumbar section of the device frame. Four additional units with the faulty part were manufactured but not yet distributed and are also being recalled.
The affected units were distributed to chiropractic offices and healthcare facilities in California, Florida, Texas, Idaho, Georgia, and Tennessee. If you own or operate one of these devices, contact Pivotal Health Solutions, Inc. immediately to report the serial number and receive instructions for service or replacement.
The recalled product
- Product
- Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
- Manufacturer
- Pivotal Health Solutions, Inc.
- Hazard
- structural-defect
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI 00850008449826
- Model Number: 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-DOC03132457210
- WTN-DOC04082457897
- WTN-DOC04082457898
- WTN-DOC03132457201
- WTN-DOC04192458307
- WTN-DOC04082457896
Distribution
Distributed in 6 states:
- CA
- FL
- GA
- ID
- TN
- TX
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