Public recall detail

Definium Tempo Pro and Definium Tempo

2023-11-23

medium
Recall Safety notice
Quick summary

Quick summary: Definium Tempo Pro and Definium Tempo. Date: 2023-11-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Definium Tempo Pro and Definium Tempo. Date: 2023-11-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandGe Hualun Medical Systems Co. Ltd.
ProductDefinium Tempo Pro and Definium Tempo
IssueMedical devices - Performance
Recall classType I
IdentificationRA-74635

Affected products

ProductDefinium Tempo Pro
Lot519793TEMPO 450371TEMPO 403777TRAD1 403777TRAD2
Model00195278118356
Serial number519793TEMPO 450371TEMPO 403777TRAD1 403777TRAD2
DescriptionDefinium Tempo Pro
ProductDefinium Tempo
Lot4650870XRR11 418628TEMPO 450742TEMPO
Model00195278070265
Serial number4650870XRR11 418628TEMPO 450742TEMPO
DescriptionDefinium Tempo

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesGe Hualun Medical Systems Co. Ltd. No.1 Yong Chang North Road, Beijing, Beijing, China, 100176
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-74635
Background{}
CompaniesGe Hualun Medical Systems Co. Ltd. No.1 Yong Chang North Road, Beijing, Beijing, China, 100176
AudiencesHealthcare
Source updated2023-11-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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