The Recall Desk
ModerateFDA (Devices)·Z-1754-2019·Announced 2019-06-19

GE Healthcare Precision 500D X-ray System Recall for Monitor Mount Failure

GE Healthcare is recalling Precision 500D X-ray systems because a CRT monitor fell off its wall mount due to product aging.

What this means for you

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 hazard involves a physical component falling due to aging, which presents a risk of injury but is not classified as a Class I or associated with reported serious injuries or deaths in the source text.

Plain-English summary

GE Healthcare, LLC is recalling the Precision 500D R&F X-ray System. This diagnostic imaging system is used for radiographic and fluoroscopic examinations, including general and pediatric exams.

The recall was initiated after a reported incident where a Distar CRT monitor fell off the monitor wall mount. The source text attributes this failure to product aging.

A total of 825 units are affected, with 38 units in the United States and 787 units outside the US. The affected units were distributed nationwide in the US and in numerous countries worldwide. Users of these systems should contact GE Healthcare for further instructions regarding the monitor mount issue.

The recalled product

Product
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard

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)

  • 204787RF1
  • 205814RF1
  • 209826500D
  • 229P500RF2
  • 410448RF
  • 417682BRF
  • 506857P500
  • 519663PR500
  • 519685PR500
  • 561791RM2
  • 603668C5
  • 618635RF
  • 636625SJR1
  • 718630PRECISION
  • 770793KP500D2
  • 810326P500
  • 850494WF4
  • 903731PRP500
  • 985230DCRF4
  • and AM16KFZ328.

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC 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 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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