The Recall Desk
HighFDA (Devices)·Z-0769-2016·Announced 2016-02-17

GE Brivo XR285amx Mobile Radiographic System Recalled for Safety Latch Failure

GE Medical Systems is recalling 126 Brivo XR285amx mobile radiographic systems worldwide because a safety latch mechanism may fail, posing a risk of bodily harm.

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 risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling 126 units of the GE Healthcare Brivo XR285amx Mobile Digital Ready Radiographic System. The recall is due to a potential failure of the safety latch mechanism located within the column that supports the horizontal arm. This latch serves as a backup safety measure in the unlikely event that the primary safety cable breaks.

The affected systems were distributed worldwide, including the United States (including Washington D.C., Puerto Rico, Virgin Islands, and Guam) and numerous international countries. The recall covers specific serial numbers, which are listed in the official FDA documentation.

A fall of the arm assembly could result in bodily harm to a person. Users of these devices should contact GE Medical Systems for further instructions on how to address the safety concern.

The recalled product

Product
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Radiographic System
Hazard
Affected units
126

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)

  • Lot or serial numbers include but not limited to: 00000086177HL3
  • 00001028564WK1
  • 115226HL3
  • 00000083538HL9
  • 00000092940HL6
  • 00000084909HL1
  • 00000081798HL1
  • 120634HL1
  • 00000084729HL3
  • 00000084161HL9
  • 00000082463HL1
  • 00000080868HL3
  • 120832HL1
  • 00000089868HL4
  • 00000082736HL0
  • 00000093379HL6
  • 00000092616HL2
  • 00000092633HL7
  • 00000081160HL4
  • 00000077253HL3

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, 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 3 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · bodily harm

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