Safety Alert for neonatal stationary incubator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by TSE spol. s r.o..

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.

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  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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: tse neonatal stationary incubator it has come to our attention that medical device manufacturer, tse spol. s r.O., has initiated a field safety corrective action concerning its neonatal stationary incubator. the affected model numbers are si-300, si-301, si-302 and si-303. the manufacturer has recently received an undesirable accident report. a newborn placed in an incubator si-301 with bed tilted to a maximal position had fallen out through a badly secured left front door during a medical treatment. during the investigation of the accident, the manufacturer has received information, that the hinge and door function was not properly tested during safety technical inspections of neonatal incubator series si-300, si-301, si-302 and si-303 (warranty check, mechanical part check, step 2.). this suspicion concerns incubators which were not under direct service supervision of tse spol. s r.O. engineers. incubators regularly serviced by tse spol. s r.O. are risk-free. furthermore, the manufacturer advises users to make the proper door function check as soon as possible. proper door function inspection of incubators not serviced directly by tse spol. s r.O. will be made by a service technician during an extra inspection. this inspection is covered in regular annual inspections for incubators serviced by tse spol. s r.O. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 january 2013.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: TSE neonatal stationary incubator
  • Manufacturer