Events

Device Recall Apollo Therapy Laser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pivotal Health Solutions 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    70473
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1250-2015
  • 사례 시작날짜
    2014-12-17
  • 사례 출판 날짜
    2015-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133854
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Lamp, infrared, therapeutic heating - Product Code ILY
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • 제품 설명
    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
  • 제조사 주소
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • 제조사 모회사 (2017)
    Pivotal Health Solutions
  • Source
    USFDA