The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2628-2016·Announced 2016-08-31

GE OEC UroView 2800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

GE OEC Medical Systems is recalling 47 OEC UroView 2800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitor to appear dark with no video displayed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 47 units of the OEC UroView 2800 fluoroscopic x-ray system. The recall is due to a firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

The affected units were distributed in the United States nationwide and in Korea. The recall involves specific monitor part numbers, including 5448359-01, 5459219-01, and 5475662-03, among others listed in the agency documentation.

This is a Class II recall, meaning the product could cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
OEC UroView 2800, fluoroscopic x-ray system
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Fluoroscopic X-Ray System
Hazard
Affected units
47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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