Recall Z-2872-2020— Ge Healthcare

Name: FDA recall Z-2872-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-08

Class II · Ongoing

Class II FDA medical device recall by Ge Healthcare, initiated 2020-05-08. It names 4 FDA 510(k) clearances: K132027, K122234, K120613 and 1 more. 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.. Reason: 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..

Recalling firm: Ge Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2020-05-08
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

4 on FDA's record

K132027 — OEC 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2014-05-01
K122234 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-08-16
K120613 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-04-06
K111551 — OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2011-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.