Recall Z-1250-2015 ยท ILY Lamp, Infrared, Therapeutic Heating
Pivotal Health Solutions
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 relax
| Date | Mar 6, 2015 (initiated Dec 17, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm, Pivotal Health Solutions, sent a letter dated December 17, 2014 on 12/17/2014 and an amended Pivotal "Urgent Medical Device Recall" letter dated February 9, 2015 to its consignees/customers. The letters described the product, problem and actions to be taken. The consignees/customers were instructed to stop using the unit and contact Pivotal Health Solution's at 1-800-743-7738 to arrange for return and repair asap; immediately examine your device inventory and quarantine any product subject to recall; if you have further distributed the product, identify your customers and notify the |
| Quantity | 35 |
| Distribution | US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060134 | APOLLO IR HEAT LAMP SYSTEM Apollo Physical Therapy Products International, Mar 21, 2006 |