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Decompression of Choice
PIVOTAL HEALTH SOLUTIONS, INC. · Model E9014-e · UDI-DI 00850020142385
ITH
Prescription
10
510(k) clearances
53
Adverse events
5
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-29 | Pivotal Health Solutions, Inc. | 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 |
| 2015-05-13 | Advanced Back Technologies, Inc. | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs |
| 2015-05-13 | Advanced Back Technologies, Inc. | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs |
| 2011-08-11 | Spinetronics, LLC | On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and repr |
| 2011-04-14 | Mettler Electronics Corp | The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Trac |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.