Heated massage tables recalled over heat components that can smolder
Pivotal Health Solutions is recalling 464 Quantum Intersegmental Tables because damage to the heat function components can lead to overheating, smoldering and melting of the vinyl cushion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: overheating that can smolder and melt the cushion beneath a patient is a burn and fire hazard, and no injuries are reported.
Plain-English summary
The Quantum Intersegmental Table, model AMQ400H, a heated massage table from Pivotal Health Solutions, is being recalled across all serial numbers.
The heat function may become damaged over time due to patients pressing on the areas with heat function components. The firm states damage to components can lead to overheating, which can lead to smoldering and melting of the vinyl cushion.
The recall covers 464 units. The product was distributed nationwide in the United States and to Canada and Japan. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Clinics operating an affected table should follow the firm's instructions.
The recalled product
- Product
- Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
- Manufacturer
- Pivotal Health Solutions, Inc.
- Category
- Medical Device — Therapy table
- Affected units
- 464
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 (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pivotal Health Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Pivotal Health Solutions, Inc.
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