Events

Recall of Device Recall Apollo Therapy Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pivotal Health Solutions.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70473
  • Event Risk Class
    Class 2
  • Event Number
    Z-1250-2015
  • Event Initiated Date
    2014-12-17
  • Event Date Posted
    2015-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133854
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lamp, infrared, therapeutic heating - Product Code ILY
  • 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.
  • 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 them at once of this product recall, and complete and return the enclosed RETURN AUTHORIZATION FORM with the units to Pivotal Service Center, 1654 Mardon Drive, Dayton, OH 45432 and the DECLARATION OF CONTAMINATION STATUS form via Fax to: 605-882-8398. If you have any questions, contact Pivotal Health Solutions Service Repair Coordinator at 800-743-7738 or email Robin@PivotalHealthSolusitons.com.

Device

Device Recall Apollo Therapy Laser
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • Product Description
    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.
  • Manufacturer
    Pivotal Health Solutions

Manufacturer

Pivotal Health Solutions
  • Manufacturer Address
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • Manufacturer Parent Company (2017)
    Pivotal Health Solutions
  • Source
    USFDA