GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws
GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.
What this means for you
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 poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling 12 units of the GE NM/CT 870 CZT system, Model Number H3906CW. These devices are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The units were distributed worldwide.
The recall was initiated because GE Healthcare became aware that rotor bearing screws were found loose on one detector in the field. This issue led to the release of one of the four rotor bearings in the detector.
The affected serial numbers are: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, and 87CY63033. Healthcare facilities should contact GE Healthcare for instructions on how to address this issue.
The recalled product
- Product
- GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 12
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 (12)
- Serial numbers: 87CY63028
- 87CZ63044
- 87CZ63045
- 87CZ63042
- 87CY63025
- 87CY63029
- 87CY63027
- 87CY63030
- 87CZ63046
- 87CY63034
- 87CY63032
- 87CY63033
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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