Health product recall

Definium Tempo Pro and Definium Tempo

Last updated

Summary

Product
Definium Tempo Pro and Definium Tempo
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Definium Tempo Pro

519793TEMPO
450371TEMPO
403777TRAD1
403777TRAD2

00195278118356

Definium Tempo

4650870XRR11
418628TEMPO
450742TEMPO

00195278070265

Issue

GE Healthcare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products. This could result in a potential fall of elements of the overhead tube suspension (OTS) assembly, which can be life threatening.

Recall start date: November 8, 2023

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Ge Hualun Medical Systems Co. Ltd.
No.1 Yong Chang North Road, Beijing, Beijing, China, 100176
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74635

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