The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1259-2019·Announced 2019-05-08

GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue

GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a structural defect could compromise safety, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 11 units of the Discovery NM/CT 670 DR system. This medical device is intended for use by trained health professionals to aid in detecting, localizing, and diagnosing diseases and organ function. The systems were distributed in the US and 18 other countries, including Austria, Canada, France, Germany, and the UK.

The recall was initiated because, during installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly. This issue could lead to the possible loss of one detector mounting design redundancy.

Healthcare facilities that have these specific systems should contact GE Healthcare for further instructions on how to address the installation issue.

The recalled product

Product
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
11

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)

  • Mfg. Lot or Serial # System ID Model

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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