Apollo — Class II medical device recall Z-1250-2015
Terminated recall by Pivotal Health Solutions, reported 2015-03-18, distributed in AR, AZ, CA, GA, IA, IL, IN, KS…. Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are
| Recall number | Z-1250-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pivotal Health Solutions, Watertown, SD, United States |
| Recall initiated | 2014-12-17 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-03-09 |
| Distributed | AR, AZ, CA, GA, IA, IL, IN, KS, MI, MN, MO, NY, OH, OR, PA, UT, WA |
| Quantity | 35 |
| Model numbers | AP2-DT |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1250-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.