Pivotal Health Solutions Recalls Apollo Laser Desktop Control Units

Plain-English summary

Pivotal Health Solutions is recalling 35 units of the Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The recall involves units manufactured prior to Pivotal Health Solutions' acquisition of the Apollo product line. The affected units were distributed to Arizona, Arkansas, California, Georgia, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, New York, Ohio, Oregon, Pennsylvania, Utah, and Washington.

The recall was initiated because the control units were equipped with an internal mounting kit that does not meet medical safety standards. The mounting kit is conductive, which increases the risk of electric shock to the user and patient. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm.

Consumers who have these units should stop using them immediately. The specific units involved are identified by the following codes: DT-1102, 1105, 1106, 1109, 1110, 1112, 1114, 1115, 1116, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, and 1309.

The recalled product

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 st

Manufacturer

Pivotal Health Solutions

Category

Medical Device — Laser Therapy

Hazard

• electric-shock

Affected units

35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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