High FDA (Devices)·Z-2190-2017·Announced 2017-06-21

GE Healthcare PET/CT X-ray Systems Recalled for Scan Timing Defect

GE Healthcare is recalling PET/CT X-ray systems because a defect 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 risk-of-harm product (medical imaging equipment) where a defect could lead to unintended scan timing, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 10,884 units of Discovery PET/CT 600, 610, 690, 710 and Optima PET/CT 560, 560FX X-ray systems. The recall was initiated after it was discovered that an issue 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. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.

The source text does not provide specific instructions for consumers or healthcare providers on how to address this issue or what actions to take.

The recalled product

Product: GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: scan-timing-defect
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)

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 →

Same manufacturer · GE Healthcare, LLC

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