Events

Commercial name: Prodigy Lunar Bone Densitometer. ANVISA registry number: 80071260163. Class of risk: III. Affected model (s); and Lot (s) / Serial number (s) affected :. The following software versions: 15, 15 SP1, and 15 SP2 are affected by the products. - Bone Densitometer (Model: DPX - NT and Record: 80071260176). - Bone Densitometry System (Model: Lunar iDXA and Record: 80071260178). - Prodigy Lunar Bone Densitometer (Model: Prodigy, Prodigy Advance, Prodigy Primo and Prodigy Pro - Record: 80071260163). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.; GE Healthcare do Brasil 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1774
  • 날짜
    2015-12-15
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the company, the occurrence of specification failure may result in an unnecessary radiation emission to the patient. However, the amount of radiation used is extremely low - less than one-tenth of a standard chest x-ray, and less than one-day exposure to natural radiation (RSNA - North American Radiological Society and ACR - American College of Radiology, 2014). The normal settings and use of ionizing radiation from a low-dose x-ray system are considered to be very safe and are unlikely to produce a short- or long-term side effect. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • 원인
    Ge healthcare became aware of non-compliance in the prodigy, idxa and dpx-nt densitometry systems. the identified fault can occur after the use of the repositioning function. it is possible that the encore software calculates an incorrect scan length, which can result in an unnecessary radiation emission to the patient.
  • 조치
    Letter delivery with reinforcement of instructions for use to mitigate risk. Field Action Code: IMF 14011. To avoid the emission of unnecessary radiation to the patient: 1) The user should check the scan length displayed on the positioning screen. Then do the scan. For anterior-posterior (AP) spine exams, most patients require a scan length of less than 20 cm. If the scan length is higher, set the value to 20 cm. 2) Monitor the exam during execution and select Abort when the user determines that the sufficient anatomical measurement area has been obtained. In spinal examinations, sufficient anatomical area is obtained when approximately half of the T12 thoracic vertebra is visible. //// Step-by-step instructions for correcting the security problem can be found in the Urgent Notice Letter or through the instructions contained in the enCORE, Rev. 12 User Manual (see page 68 for Abortion Measurement [Abort Measurement] and page 83 for AP Spine Analysis]. Following these instructions correctly will prevent the emission of unnecessary radiation to the patient.

Device

Commercial name: Prodigy Lunar Bone Densitometer. ANVISA registry number: 80071260163. Class of r...

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.; GE Healthcare do Brasil