Public recall detail

OEC Elite and OEC Mobile C-arms

2024-12-18

medium
Recall Safety notice
Quick summary

Quick summary: OEC Elite and OEC Mobile C-arms. Date: 2024-12-18.

Recommended action

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

Recall details

Quick summary: OEC Elite and OEC Mobile C-arms. Date: 2024-12-18.

Official details

Affected product details

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

BrandGE OEC Medical Systems Inc.
ProductOEC Elite and OEC Mobile C-arms
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76718

Affected products

ProductOEC Mobile Elite C-Arms General Surgical Platform Non-Motorized Cooling
LotE9-2710 E9-2720 E9-0539
ModelOEC 9900 ELITE
Serial numberE9-2710 E9-2720 E9-0539
DescriptionOEC Mobile Elite C-Arms General Surgical Platform Non-Motorized Cooling
ProductGE OEC Elite
LotFAXXTE01158 FBXXTE02995
ModelOEC ELITE
Serial numberFAXXTE01158 FBXXTE02995
DescriptionGE OEC Elite

Issue

GE Healthcare has become aware that recently manufactured OEC Elite and OEC Mobile C-arms, as well as recently replaced x-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/9800 Mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Recall start date: December 5, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesGE OEC Medical Systems Inc. 384 Wright Brothers Drive, Salt Lake City, Utah, United States, 84116
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76718
Background{}
CompaniesGE OEC Medical Systems Inc. 384 Wright Brothers Drive, Salt Lake City, Utah, United States, 84116
AudiencesHealthcare
Source updated2024-12-18

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

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