The Recall Desk
HighFDA (Devices)·Z-0770-2016·Announced 2016-02-17

GE Healthcare Optima XR200amx Mobile Radiographic System Recalled for Safety Latch Failure

GE Medical Systems is recalling 895 Optima XR200amx mobile radiographic systems worldwide due to a potential safety latch mechanism failure that could cause the arm assembly to fall.

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 is classified as FDA Class II and involves a risk of bodily harm from a falling arm assembly, but no injuries or deaths are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Medical Systems, LLC is recalling 895 units of the Optima XR200amx 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 safety latch serves as a backup in the unlikely event that the primary safety cable breaks.

A fall of the arm assembly could result in bodily harm to a person. The affected units were distributed worldwide, including the United States, Washington D.C., Puerto Rico, the Virgin Islands, and Guam, as well as numerous countries across Asia, Europe, Africa, and the Americas. Specific serial numbers are listed in the official recall documentation.

Healthcare facilities and users of these systems should contact GE Medical Systems for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Radiographic Equipment
Hazard
Affected units
895

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: 00001031869WK9
  • 00001031925WK9
  • 00000081156HL2
  • GEGR2170
  • 00001033726WK9
  • 00000119120HL4
  • 00000084104HL9
  • 00001033405WK0
  • 00000085648HL4
  • 00001033548WK7
  • 1035415WK7
  • 124175HL1
  • 122205HL8
  • 1036207WK7
  • 00000086387HL8
  • 00000104902HL2
  • 00000087904HL9
  • 00000087902HL3
  • 00000106045HL8

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

See all →

Same hazard · falling object

See all →