Z-1060-2017Class II

OEC 9900 Elite. MDL Numbers: D148942, D155043

Name: Z-1060-2017 OEC 9900 Elite. MDL Numbers: D148942, D155043
Creator: GE OEC Medical Systems, Inc
Published: 2016-12-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-12-27 / Terminated / root cause: packaging

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 9900 Elite. MDL Numbers: D148942, D155043 on 2016-12-27. FDA classified it as Class II and gives the reason as "GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1060-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-01-20
Terminated: 2018-07-12
Recalling firm: GE Healthcare
Product: OEC 9900 Elite. MDL Numbers: D148942, D155043
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.
Quantity in commerce: 26,256 total
Distribution: Worldwide including govt/VA/military and foreign consignees.
Product codes and lots: Manufactured from Oct 2005 to present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1060-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1059-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-1060-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)