Trademark Elevating Table E9012-LRecalls & reported problems
Pivotal Health Solutions, Inc. · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850008449826), received between May 16, 2024 and Jun 27, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 29, 2024Open, Classified
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.
Z-2326-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A WELD ON PART E7130 FAILED WHILE THE TABLE WAS IN USE. THERE WAS NO INJURY, HOWEVER THE DOCTOR'S FLOOR WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629993 ↗MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED THE MANUFACTURER TO REPORT THAT AS THEY WERE UNCRATING THE TABLE AND WERE IN THE PRCOESS OF MOVING THE TABLE, THE LUMBAR SECTION OF THE TABLE WAS OBSERVED AS NOT BEING HORIZONTAL AND LEVEL WITH THE OTHER CUSHION SECTIONS, IT WAS TIPPED DOWNARD. PICTURES WERE SENT BY THE CUSTOMER TO THE MANUFACTURER AND IT WAS DETERMINED THAT THERE MAY BE A PARTIAL WELD BREAK AND THE IMMEDIATE DECISION WAS MADE TO HAVE THE TABLE SHIPPED BACK TO THE MANUFACTURER. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19342108 ↗MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE WELD ON THE LUMBAR SECTION OF THE TABLE FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19336621 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.