GE Healthcare Recalls Nuclear Medicine Systems Due to Loose Rotor Bearing Screws
GE Healthcare is recalling 52 nuclear medicine systems worldwide because loose rotor bearing screws caused a bearing to release in one field unit.
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 mechanical defect in a medical device that resulted in a component release, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 52 units of Discovery 670 DR, NM/CT 870 DR, Discovery NM670 Pro, and Discovery 670 ES nuclear medicine systems. The recall is due to a defect where rotor bearing screws were found loose on one detector in the field, which led to the release of one of the four rotor bearings in that detector.
The affected systems are intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, and diagnosing diseases and organ function. The recall covers units distributed worldwide. Specific serial numbers for the affected models are listed in the agency's recall record.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 52
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)
- Discovery 670 DR (Model H3100BT)
- Serial Numbers: DRGY56033
- DRGY56037
- DRGY56035
- DRGY56030
- DRGZ56043
- DRGZ56042
- DRGY56032
- DRGY56031
- DRGY56034
- DRGY56036 NM/CT 870 DR (Model 3100Q)
- Serial Numbers: 870Y64066
- and (Model H3100AS)
- Serial Numbers: 870Y64077
- 870Y64064
- 870Y64081
- 870Y64079
- 870Y64067
- 870Y64074
- 870Z64117
Distribution
Distribution scope not specified by the agency.
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.
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Similar recalls
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FDA (Devices) · 2020-09-30
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