Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Candela.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 026 01 19 000
  • Event Initiated Date
    2019-01-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13735
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Important software changes being made to your gentle pro laser system from the previous software (2.0, 2.1 and 2.2) to this rev 2.3a software release. major technical rev 2.3a changes: • added an alternative preventative maintenance laser notification that is based on number of pulses and/or time • improved security to access maintenance mode by authorized service representatives. • improves the safety for the patient and the system by preventing specific faults not to happen.

Device

Gentlelase PRO
  • Model / Serial
    System Model Numbers: • 9914-9015 • 9914-9020 • 9914-9030 • 9914-9035
  • Product Description
    Hair removal laser
  • Manufacturer
    Candela

Manufacturer

Candela
  • Manufacturer Parent Company (2017)
    Lupert Ltd
  • Manufacturers representative
    Imdad Medical Business Company Ltd.
  • Source
    SFDA