Z-2125-2012Class II

OEC 9800 Plus Digital; MDL number A349855

Name: Z-2125-2012 OEC 9800 Plus Digital; MDL number A349855
Creator: GE OEC Medical Systems, Inc
Published: 2007-03-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-03-27 / Terminated / root cause: software

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical... on 2007-03-27. FDA classified it as Class II and gives the reason as "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2125-2012
Classification: Class II
Status: Terminated
Initiated: 2007-03-27
Posted: 2012-08-01
Terminated: 2012-08-02
Recalling firm: GE Healthcare
Product: OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
Root cause tag: software
FDA root cause: Software design
Action: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notices dated October 11, 2006 and February 21, 2007 via certified mail delivery letter to affected customers. The notices identified the affected products, problem and actions to be taken. Customers were informed that a GEHC OEC field service engineer would be contacting their facility to arrange to have a replacement hard disk drive installed on the affected system(s). Customers were instructed to ensure that images on the hard disk drive were stored via an alternate permanent media as the hard disk drive approaches the 170 image capacity until a GEHC OEC field service engineer had replaced the drive. For questions regardiug this issues contact the service team at 800-874-7378.
Quantity in commerce: Part of a total of 82 units distributed.
Distribution: Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.
Product codes and lots: 62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2125-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2125-2012	Class II	Terminated	FDA Mandated	2012-08-08	2012-08-01
Z-2126-2012	Class II	Terminated	FDA Mandated	2012-08-08	2012-08-01
Z-2127-2012	Class II	Terminated	FDA Mandated	2012-08-08	2012-08-01

Product code IZL

K021049Class IIOec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems / cleared 2002-04-17

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)