The Recall Desk
HighFDA (Devices)·Z-1547-2021·Announced 2021-05-19

GE Healthcare Recalls NM/CT 870 DR Scanners for Radiation Exposure Shift

GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.

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 device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling NM/CT 870 DR Nuclear Medicine / CT Scanners due to a potential issue that could cause a shift in the CT radiation exposure range of up to 5cm compared to the intended range. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console.

In some cases, this issue may necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation. A total of 242 units were distributed worldwide, with 17 units distributed in the United States.

The recalled product

Product
NM/CT 870 DR Nuclear Medicine / CT Scanners
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard

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)

  • GTIN*00840682140836

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · radiation exposure

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