Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

OEC 9900 Elite. MDL Numbers: D148942, D155043

FDA Recall Z-1060-2017 · Posted 2017-01-20

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-12-27
Date Terminated2018-07-12
Product Quantity26,256 total

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.

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

Worldwide including govt/VA/military and foreign consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122234OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012-08-16K120613OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012-04-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑