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Open, Classified

GE HealthCare OEC 9800.

FDA Recall Z-2341-2025 · Posted 2025-08-22

Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-07-02

Reason for Recall

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

Firm Action

GE HealthCare will send a customer letter providing safety instructions as an immediate mitigation, to communicate the risk of additional radiation and that the equipment should only be used by personnel properly trained and authorized in the use of ionizing radiation. A user should observe proper safety practices during equipment operation as required by the operator manual. GE HealthCare will correct all affected OEC 9800 and OEC 9900 Elite systems (28 units) by visually inspecting for the presence of lead shield tape on the collimator cover and replacing the collimator cover if it is found non-compliant, at no cost to the customer.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111551OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc. · 2011-10-04K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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