GE Healthcare Recalls 27 NM/CT 870 DR Systems Due to Detector Screw Issue
GE Healthcare is recalling 27 NM/CT 870 DR systems because detector screws may not be secured correctly, potentially compromising detector 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a potential loss of design redundancy rather than an immediate, reported safety failure.
Plain-English summary
GE Healthcare, LLC is recalling 27 units of the GE Discovery NM/CT 870 DR system. These medical devices are intended for use by trained health professionals to aid in detecting, localizing, and diagnosing diseases and organ function.
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 can lead to the possible loss of one detector mounting design redundancy.
The affected units were distributed in the US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, and the UK. Users should contact GE Healthcare for instructions on how to address the issue.
The recalled product
- Product
- NM/CT 870 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, abnormalities…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 27
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.
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