Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
Reported: July 17, 2024 Initiated: April 29, 2024 #Z-2326-2024
Product Description
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
Reason for Recall
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.
Details
- Recalling Firm
- Pivotal Health Solutions, Inc.
- Units Affected
- 32 tables
- Distribution
- Distributed to CA, FL, TX, ID, GA, and TN
- Location
- Watertown, SD
Frequently Asked Questions
What product was recalled? ▼
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.. Recalled by Pivotal Health Solutions, Inc.. Units affected: 32 tables.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2326-2024.
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