Reported Mar 18, 2015 · Terminated
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in…
Pivotal Health Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pivotal Health Solutions · 724 Oakwood Road · Watertown, SD · 57201-4133
Is this the product you have?
- Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
- Lot codes and dates
DT-11021105110611091110111211141115111611181119112011211121112211231124112511261127112811291130113111321134113511361137113811391302130313041309
- Amount recalled
- 35
Where it was sold
Why it was recalled
Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.
This product could cause temporary or reversible health problems — stop using it.
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