Agency classClass IIOur severity:High FDA (Devices)·Z-0768-2016·Announced 2016-02-17

GE Healthcare Optima XR220amx Mobile Radiographic System Recalled for Safety Latch Failure

GE Medical Systems is recalling 2,389 Optima XR220amx 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 involves a risk-of-harm product where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling 2,389 units of the Optima XR220amx 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.

If the safety latch fails, the arm assembly could fall, which could result in bodily harm to a person. The affected units were distributed worldwide, including in the United States, Washington D.C., Puerto Rico, the Virgin Islands, Guam, and numerous countries across Asia, Europe, Africa, and the Americas.

Healthcare facilities and consumers with this device should contact GE Medical Systems for instructions on how to address the defect. The recall number is Z-0768-2016.

The recalled product

Product: GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Radiographic System
Hazard: falling-object
bodily-harm
Affected units: 2,389

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 including but not limited to: 00001033715WK2
12535HL3
00000078321HL7
00000096815HL6
00000081147HL1
00001032621WK3
00000092076HL9
00000092382HL1
00000460115GE9
00000079932HL0
D3s14793
00000088642HL4
116635HL4
120632HL5
GEGR2411
GEGR5073
00001027151WK8
00000129105HL3
261417HP0
261416HP2

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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