Definium Tempo Pro and Definium Tempo
Brand(s)
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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