Events

Field Safety Notices about Ondal Acrobat 2000 (AC2000)

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

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
    Field Safety Notice
  • Event Number
    SN2011(07)
  • Date
    2011-05-12
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ondal-acrobat-2000-(ac2000)&id=3587f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The acrobat 2000 spring-loaded arms could break. the acrobat 2000 spring arm has been used by a number of different manufacturers to support operating lights and monitors which have been placed on the market in ireland.
  • Action
    The IMB advises that users:  • Identify the affected spring arms in your facility and contact the appropriate manufacturer for further guidance.  • Follow the manufacturer’s recommendations as outlined in the associated field safety notices.  • Users are advised to exercise caution when moving or repositioning devices connected to these spring arms pending upgrade / inspection by the  manufacturer.

Device

Ondal Acrobat 2000 (AC2000)
  • Model / Serial
  • Product Description
    Ondal Acrobat 2000 (AC2000)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA