Pivotal Health Solutions
Pivotal Health Solutions appears in FDA public data with 4 recalls, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0587-2026, Class II) was initiated on Oct 9, 2025. Its most recent 510(k) clearance was granted on Sep 10, 2014.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0587-2026 | Class II | Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table | Oct 9, 2025 |
| Z-0588-2026 | Class II | Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table | Oct 9, 2025 |
| Z-2326-2024 | Class II | Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with pract | Apr 29, 2024 |
| Z-1250-2015 | Class II | Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intend | Dec 17, 2014 |