Recall Z-1250-2015— Pivotal Health Solutions

Name: FDA recall Z-1250-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Class II · Terminated

Class II FDA medical device recall by Pivotal Health Solutions, initiated 2014-12-17, terminated 2016-03-09. It names one FDA 510(k) clearance: K060134. 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.. Reason: 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..

Recalling firm: Pivotal Health Solutions
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Terminated: 2016-03-09
Firm location: Watertown, SD, United States

510(k) clearances named in this recall

1 on FDA's record

K060134 — APOLLO IR HEAT LAMP SYSTEMApollo Physical Therapy Products International·cleared 2006-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.