GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 147 Discovery NM 630 nuclear imaging systems to update maintenance procedures and prevent loose fasteners from causing parts to fall on patients.
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 addresses a risk-of-harm product where a component could fall on a patient, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
GE Healthcare, LLC is recalling 147 units of the Discovery NM 630 dual detector free-geometry integrated nuclear imaging system. The affected models include H3100RC, H3100RD, and H2401LW. These systems are medical tools used by trained healthcare professionals to detect, localize, and diagnose diseases, as well as to assess organ function.
The recall is being conducted to update the Preventative Maintenance procedure and schedule. An additional check for loose fasteners on the Nuclear Medicine systems has been added. This specific check is intended to prevent a portion of the system from falling onto a patient during a scan, which could occur if the fasteners securing the camera to the gantry become loose.
The affected units were distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, and DC) and numerous international countries. No specific dates or lot numbers are provided in the source text. Healthcare facilities should contact GE Healthcare for instructions on updating their maintenance procedures.
The recalled product
- Product
- Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 147
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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