The Recall Desk
HighFDA (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.

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 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
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 →

Related recalls

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