GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect
GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.
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 medical device where a specific injury (patient finger injury) has been reported, but the hazard is not classified as FDA Class I or associated with death or serious injury, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling 526 units of the Discovery NM 530c Nuclear Medicine system. The recall was initiated because a small number of these systems were identified as operating without currently updated software.
The hazard is associated with the automatic Unload feature. In a recent event, a patient's finger was injured during the Unload process while this feature was being used on a system that did not have the current software installed.
The affected systems were distributed domestically across 38 U.S. states and the District of Columbia, as well as internationally to 27 countries. Users of these systems should contact GE Healthcare to verify their software status and apply the necessary updates.
The recalled product
- Product
- System, Tomography Computed Emmission
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 526
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 (20)
- Model for Discovery NM 530c: 5248934
- 5166674-01
- H3000SA
- H3001JA
- H3001JD. Serial Numbers: 19016
- 0000000ME11041
- 19069
- 19098
- 19082
- 19070
- 19086
- 19027
- 19044
- 19083
- 19065
- 19062
- 19048
- 19009
- 19109
- 19015
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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