Recall Z-2629-2016— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-07-22, terminated 2016-12-19. It names 5 FDA 510(k) clearances: K111551, K022069, K021049 and 2 more. Product: OEC 9800, fluoroscopic x-ray system. Reason: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-22
- Terminated
- 2016-12-19
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
5 on FDA's record- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K022069 — OEC FLUOROTRAK 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
- K993687 — UROVIEW 2800
- K974355 — INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
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
OEC 9800, fluoroscopic x-ray system
Reason for recall
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.