Events

Safety Alert for Amplimat 5-Field Chamber

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Medical Systems.

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
  • Date
    2012-10-19
  • Event Date Posted
    2012-10-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips amplimat 5-field chamber medical device manufacturer, philips medical systems, has issued a medical device safety alert concerning all units of digitaldiagnost, essenta dr, essenta dr compact, buckydiagnost, easydiagnost eleva and traumadiagnost using the 5-field amplimat chamber, serial numbers from 11320067 to 11321695 and from 11322000 to 11322231. if direct radiation hits an amplimat field (selected or unselected), the amplimat signal amplifier can enter an undefined state, and one or more of the following automated exposure control (aec) exposures (using the amplimat) can be overexposed. as a result, the generator does not switch off the exposure when the intended dose is reached; however, it does switch off when the backup shutoff condition is reached. if the pre-programmed apr/epx settings are used, the overexposure is small and the image generated is usable for diagnostic purposes. if the operator overrides the pre-programmed settings, the image generated may be unusable (i.E. not correctly exposed) and more radiation may be administered than intended. the manufacturer advised the affected users to take the following actions: use the pre-programmed apr/epx settings for aec technique exposures. if overriding the apr/epx settings, monitor the exposure time. if the exposure time is longer than expected, abort the exposure. the decision if a retake is required or not should be based on the expected benefit in relation to the radiation risk. the manufacturer will instruct field service engineer to remove the affected amplimat chamber for devices with serial numbers from 11320067 to 11321695 and from 11322000 to 11322231, and install a new one. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

Amplimat 5-Field Chamber
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Amplimat 5-Field Chamber
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH