Events

Safety Alert for Akron Tilt Table

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

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
    2018-05-23
  • Event Date Posted
    2018-05-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180523a.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: arjohuntleigh akron tilt table medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its akron tilt table [model number: a8652, a8652t; serial number: between p0167499 and p0418644]. the manufacturer received a customer complaint related with akron tilt table middle section frame breakage in its post-market surveillance monitoring. the investigation showed that one of critical welds in the part was missing. there was no injury related to this incident. according to the manufacturer, the issue is related with potential hazard for patients and if the affected device will be used it can lead to collapse during movement to the vertical position. in the worst case, scenario user can fall down with the upholstery (if not protected with belts). the manufacturer will arrange a service technician to visit the facilities to carry out welds presence verification and the frame replacement if a missing weld/missing welds would be detected. it is not recommended to use the couch until action would be taken by the manufacturer. the affected customers are instructed to ensure that all caregivers and users of the affected devices are made aware of the field safety notice and all listed devices at their facilities are available to be corrected during service technician visit. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 may 2018.

Device

Akron Tilt Table
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ArjoHuntleigh Akron Tilt Table
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh