Z-2872-2020Class II

The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic...

Name: Z-2872-2020 The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic...
Creator: Ge Healthcare
Published: 2020-05-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-05-08 / Open, Classified / root cause: manufacturing process

FDA source

Ge Healthcare began a recall of The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples... on 2020-05-08. FDA classified it as Class II and gives the reason as "GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2872-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-08
Posted: 2020-08-27
Recalling firm: GE Healthcare
Product: The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
Product code: RCC C-Arm Fluoroscopic X-Ray System
Reason for recall: GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Quantity in commerce: 221
Distribution: Nationwide
Product codes and lots: OEC 9800, OEC 9900 Elite

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2872-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2872-2020	Class II	Ongoing	FDA Mandated	2020-09-09	2020-08-28

Product code RCC

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)