CLASS II Device recall · Reported 18 Mar 2015 · FDA Enforcement Report

Apollo (cold) Laser Desktop Control Units recalled

Pivotal Health Solutions is recalling Apollo (cold) Laser Desktop Control Units, distributed in 17 states. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, 1309.

Quantity recalled35

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1250-2015
FDA event ID: 70473
Recalling firm: Pivotal Health Solutions, Watertown, SD
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2014
FDA classified: 6 Mar 2015
Reported: 18 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

17 Dec 2014	Recall initiated by company
6 Mar 2015	Classified by FDA	+79 days
18 Mar 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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.

Where it was distributed

US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.

Arkansas Arizona California Georgia Iowa Illinois Indiana Kansas Michigan Minnesota Missouri New York Ohio Oregon Pennsylvania Utah Washington

Questions about this recall

Is Apollo (cold) Laser Desktop Control Units recalled?

Yes. Pivotal Health Solutions recalled Apollo (cold) Laser Desktop Control Units on 17 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1250-2015.

Why was it recalled?

Which lots are affected?

DT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, 1309.

Where was it sold?

US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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