Health product recall

Definium Tempo Pro and Definium Tempo

Last updated

Summary

Product
Definium Tempo Pro and Definium Tempo
Issue
Medical devices - Performance issue
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