FDA Device recall Z-1250-2015
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum…
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum… by Pivotal Health Solutions, citing 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 pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1250-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-17 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pivotal Health Solutions |
| Distribution | AR, AZ, CA, GA, IA, IL, IN, KS, MI, MN, MO, NY, OH, OR, PA, UT, WA |
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.
Identifiers
| code_info | DT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1250-2015%22
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