The Recall Desk
HighFDA (Devices)·Z-2195-2017·Announced 2017-06-21

GE Healthcare Discovery NM/CT 670 CZT X-ray System Recall

GE Healthcare is recalling Discovery NM/CT 670 CZT X-ray systems because a defect may cause scans to start before the 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 10,884 units of the Discovery NM/CT 670 CZT X-ray system. 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 products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. The source text does not specify the exact number of units distributed in each specific region.

Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this issue. The source text does not provide specific contact details or remediation steps.

The recalled product

Product
GE Healthcare Discovery NM/CT 670 CZT X-ray system
Manufacturer
GE Healthcare, LLC
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 →