Health product recall

OEC Elite and OEC Mobile C-arms

Last updated

Summary

Product
OEC Elite and OEC Mobile C-arms
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 catalog number
OEC Mobile Elite C-Arms General Surgical Platform Non-Motorized Cooling E9-2710 E9-2720 E9-0539 OEC 9900 ELITE
GE OEC Elite FAXXTE01158 FBXXTE02995 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

GE OEC Medical Systems Inc.

384 Wright Brothers Drive, Salt Lake City, Utah, United States, 84116

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76718

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