Events

Safety Alert for 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).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.; GE Healthcare do Brasil.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1774
  • Date
    2015-12-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Action
    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