CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

OEC UroView 2800, fluoroscopic x-ray system recalled

GE OEC Medical Systems is recalling OEC UroView 2800, fluoroscopic x-ray system, distributed nationwide in the US. The recall was initiated on 22 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmonitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347

Quantity recalled47 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2628-2016
FDA event ID: 74808
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 22 Jul 2016
FDA classified: 23 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

22 Jul 2016	Recall initiated by company
23 Aug 2016	Classified by FDA	+32 days
31 Aug 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

OEC UroView 2800, fluoroscopic x-ray system

Where it was distributed

Distribution US nationwide and Korea.

Nationwide

Questions about this recall

Why was it recalled?

A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

Which lots are affected?

monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347

Where was it sold?

Distribution US nationwide and Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 74808

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS II	OEC 9800, fluoroscopic x-ray system recalled by GE OEC Medical Systems	GE OEC Medical Systems	Other	Nationwide

More recalls from GE OEC Medical Systems

All 47

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS II	OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC Elite recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 3D recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
9 Aug 2023Device	CLASS II	OEC Elite Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

Other Imaging Equipment recalls

All 2,341

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Philips EPIQ Elite Diagnostic Ultrasound System recalled	Philips Ultrasound	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical	Avid Medical	Sterility	4 states