International Medical Devices Database

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
SN2009(02)
Date
2009-04-20
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/spacelabs-ultraview-digital-telemetry-transmitter-model-90478&id=8c93f825-9782-6eee-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
Spacelabs healthcare issued an ‘urgent – medical device correction’ letter in august 2008 advising all customers of several circumstances where the device alarm may fail.
Action
Ensure that the appropriate personnel are made aware of this notice. Advise Hospital Services Ireland of the number and location of all affected devices in your hospital / health board. Ensure that the software upgrade is completed on all devices.

Device

Spacelabs Ultraview Digital Telemetry Transmitter Model 90478

Model / Serial
Product Description
Spacelabs Ultraview Digital Telemetry Transmitter Model 90478
Manufacturer
Spacelabs Healthcare Limited

Manufacturer

Spacelabs Healthcare Limited

Manufacturer Parent Company (2017)
OSI Systems Inc
Source
HPRA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

Field Safety Notices about Spacelabs Ultraview Digital Telemetry Transmitter Model 90478

What is this?

Device

Spacelabs Ultraview Digital Telemetry Transmitter Model 90478

Manufacturer

Spacelabs Healthcare Limited