The Recall Desk
HighFDA (Devices)·Z-1865-2012·Announced 2012-07-04

GE OEC Uroview 2800 Recalled for Intermittent Safety Issues

GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with potential safety issues such as incorrect image display and system lock-ups during procedures, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 717 units of the OEC Uroview 2800 fluoroscopic imaging system, model number A349855. The devices were distributed worldwide and are designed to provide fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures.

The recall was initiated in November 2006 due to several intermittent potential safety issues. These issues include navigation tracking inaccuracy, system lock-ups, incorrect image display, and incorrect dose area calculated air kerma in "film mode" and "digital spot mode." Additionally, the system may fail to reboot.

The recall affects 717 specific units identified by serial numbers listed in the official FDA record. Healthcare facilities and users of these devices should contact GE OEC Medical Systems for further instructions on how to address these safety concerns.

The recalled product

Product
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Fluoroscopic Imaging System
Hazard
Affected units
717

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)

  • All Serial Numbers: P4-0004-L
  • P4-0005-L
  • P4-0006-R-RC1
  • P4-0008-R
  • P4-0011-L
  • P6-0654-R
  • P4-0012-R
  • P4-0013-L
  • P4-0014-L
  • P4-0015-L
  • P4-0016-L
  • P4-0017-L
  • P4-0018-L
  • P4-0019-R
  • P4-0020-L
  • P4-0021-L
  • P4-0022-R
  • P4-0023-L
  • P4-0024-R
  • P4-0025-R

Distribution

Distribution scope not specified by the agency.

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