The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1250-2015·Announced 2015-03-18

Pivotal Health Solutions Recalls Apollo Laser Desktop Control Units

Pivotal Health Solutions is recalling 35 Apollo Laser Desktop Control Units because internal mounting kits do not meet safety standards, increasing the risk of electric shock.

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: The recall involves a risk-of-harm product (electric shock) where injury has not yet been reported, which corresponds to a High severity score of 3 according to the rubric.

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…
Manufacturer
Pivotal Health Solutions
Category
Medical Device — Laser Therapy
Hazard
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.

Lot numbers (20)

  • DT-1102
  • 1105
  • 1106
  • 1109
  • 1110
  • 1112
  • 1114
  • 1115
  • 1116
  • 1118
  • 1119
  • 1120
  • 1121
  • 1122
  • 1123
  • 1124
  • 1125
  • 1126
  • 1127
  • 1128

Distribution

Distributed in 17 states:

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