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.
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 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.
See all 6 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateGE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Screws
FDA (Devices) · 2020-09-30
- ModerateGE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue
FDA (Devices) · 2019-05-08
- ModerateGE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws
FDA (Devices) · 2020-09-30
- ModerateGE Healthcare Recalls NM/CT 870 DR Systems Due to Loose Screws
FDA (Devices) · 2020-09-30
- ModerateGE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect
FDA (Devices) · 2019-05-08
- HighGE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue
FDA (Devices) · 2019-05-08