Z-2262-2012Class II

GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable...

Name: Z-2262-2012 GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable...
Creator: GE OEC Medical Systems, Inc
Published: 2008-10-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-10-10 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger... on 2008-10-10. FDA classified it as Class II and gives the reason as "GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2262-2012
Classification: Class II
Status: Terminated
Initiated: 2008-10-10
Posted: 2012-08-23
Terminated: 2013-01-10
Recalling firm: GE Healthcare
Product: GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Safety Advisory Notice was sent to consignees on October 10, 2008. The letter identified the affected product and notified customers of the situation, along with instructing them to discontinue use until proper validation and instruction update for cable use was completed. GEHC OEC was to have contacted customers when the solution became available and resolved it at no cost to the customer.
Quantity in commerce: 149 units
Distribution: Nationwide distribution.
Product codes and lots: Serial Numbers: 82-1138, 82-1586, 82-2089, 82-2117, 82-2182, 82-2214, 82-2226, 82-2262, 82-2264, 82-2308, 82-2312, 82-2314, 82-2321, 82-2328, 82-2380, 82-2391, 82-2438, 82-2483, 82-2512, 82-2516, 82-2535, 82-2722, 82-2796, 82-2821, 82-2846, 82-2848, 82-3052, 82-3055, 82-3129, 82-3144, 82-3170, 82-3171, 82-3201, 82-3256, 82-3267, 82-3314, 82-3350, 82-3361, 82-3377, 82-3467, 82-3468, 82-3659, 82-3709, 82-3722, 82-3859, 82-7016-MH, 82-7022-MH, 82-7037-MH, 82-7055-MH, 82-7062-MH, 82-7080-MH, 82-7086-MH, 82-7105-MH, 82-7114-MH, 82-7124-MH, 82-7131-MH, 82-7133-MH, 82-7137-MH, 82-7141-MH, 82-7154-CMH, 82-7155-MH, 82-7156-MH, 82-7161-MH, 82-7175-MH, 82-7189-MH, 82-7190-MH, 89-1441, 8S-1053, 8S-1436, 8S-2059-C, 8S-7021-CMH, 8S-7023-CMH, 8S-7040-CMH, 8S-7087-CMH, 8S-7164-CMH, DEMO/8S-1355-N, DEMO/E3-7002-MH, E2-0049, E2-0088, E2-0111, E2-0262, E2-7001-MH, E2-7007-MH, E2-7010-MH, E2-7014-MH, E2-7015-MH, E2-7031-MH, E2-7032-MH, E2-7035-MH, E2-7043-MH, E2-7059-MH, E2-7061-MH, E2-7067-MH, E2-7075-MH, E2-7076-MH, E2-7015-MH, & rENTAL/82-7004-MH.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2262-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-23

Product code OXO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)