GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems
GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a reported patient injury (pinched fingers), which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 556 units of the Ventri Discovery NM 530c and Ventri with Premium Table Discovery NM 530c nuclear imaging systems, models H3000ZW and H3000SA. The recall covers units distributed worldwide, including the United States and numerous international countries.
The recall was initiated after an incident in which a patient was injured during an unload following an exam. The hazard involves the patient's fingers potentially being pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify the exact corrective action or the number of additional injuries reported beyond the initial incident.
The recalled product
- Product
- Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 556
Distribution
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