Z-2342-2025Class II

GE HealthCare OEC 9900 Elite C-arm Systems

Name: Z-2342-2025 GE HealthCare OEC 9900 Elite C-arm Systems
Creator: GE Medical Systems, LLC
Published: 2025-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-07-02 / Open, Classified

FDA source

GE Medical Systems, LLC began a recall of GE HealthCare OEC 9900 Elite C-arm Systems on 2025-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2342-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-02
Posted: 2025-08-22
Recalling firm: GE Healthcare
Product: GE HealthCare OEC 9900 Elite C-arm Systems.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
FDA root cause: Radiation Control for Health and Safety Act
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.
Distribution: US Nationwide distribution.
Product codes and lots: GTIN: 00840682114349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2342-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2025	Class II	Ongoing	FDA Mandated	2025-09-03	2025-08-22
Z-2342-2025	Class II	Ongoing	FDA Mandated	2025-09-03	2025-08-22

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)