The Recall Desk
HighFDA (Devices)·Z-2187-2017·Announced 2017-06-21

GE Healthcare Recalls Innova IGS 540 ACT X-ray Systems

GE Healthcare is recalling 10,884 Innova IGS 540 ACT X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

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 medical device with a functional defect that could lead to unintended radiation exposure or procedural errors. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.

Plain-English summary

GE Healthcare, LLC is recalling 10,884 units of the Innova IGS 540 ACT X-ray system. The recall is due to a discovered issue that can result in a scan starting before the prescribed delay has completed.

The affected devices were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries such as Japan, Mexico, the United Kingdom, and Germany. The source text does not specify specific lot numbers or serial codes for the affected units.

The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it report any injuries or illnesses associated with this defect. Users of these systems should contact GE Healthcare for further information regarding the recall and potential corrective actions.

The recalled product

Product
GE Healthcare lnnova IGS 540 ACT X-ray system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
10,884

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 (1)

  • n/a

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 16 recalled by GE Healthcare, 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 16 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · unintended radiation exposure

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