GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of 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 structural defect in a medical device that could lead to the loss of a detector, posing a risk of harm to patients or equipment, but no injuries or illnesses have been reported.
Plain-English summary
GE Healthcare, LLC is recalling 57 units of the Discovery NM 630 nuclear imaging system. The recall is due to a manufacturing issue where detector screws may not have been secured correctly during installation of systems delivered with dismounted detectors.
This defect leads to the possible loss of one detector mounting design redundancy. The affected systems were distributed in the US and 18 other countries, including Austria, Canada, France, Germany, and the UK.
The source text does not specify instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 57
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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