Agency classClass IIOur severity:High FDA (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.

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 3/5 (High).

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: falling-object
bodily-harm
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 →

Same manufacturer · GE Medical Systems, LLC

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