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Pivotal Health Solutions recalls Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in
Recalled March 18, 2015 · FDA recall Z-1250-2015 · Pivotal Health Solutions
Hazard
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. · FDA Class II
Units
35
Sold at
US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
Description
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.
Product
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.
Manufacturer(s)
Pivotal Health Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →