NMCT 850Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

8 other recalls cover devices cleared under the same FDA submission (K173816); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 19, 2022Open, Classified

   A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

   Z-1058-2023 · Root cause: Process control · FDA record ↗

2. Feb 7, 2021Open, Classified

   GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

   Z-1545-2021 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173816. One submission often covers many models, so check the product and lot details in each record.

• Z-1546-2021 · Feb 7, 2021 · Open, Classified
  NM/CT 860 Nuclear Medicine / CT Scanners
• Z-0853-2021 · Dec 10, 2020 · Terminated
  GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
• Z-0854-2021 · Dec 10, 2020 · Terminated
  GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
• Z-2991-2020 · Aug 14, 2020 · Terminated
  NM/CT 850 Model Number: H3907AD
• Z-2992-2020 · Aug 14, 2020 · Terminated
  NM/CT 860, SPECT/CT
• Z-1262-2019 · Mar 20, 2019 · Terminated
  NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It i
• Z-1263-2019 · Mar 20, 2019 · Terminated
  NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It
• Z-1261-2019 · Mar 20, 2019 · Terminated
  NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioi