Discovery NM (CT scanner)

2023: Recall of defective tomographs

In mid-February 2023, GE HealthCare recalls defective imaging tomographs after identifying problems with two mechanisms in the devices, which can cause the equipment to crush patients.

The US Department of Health attributed the recall of the GE HealthCare 600/800 series systems for nuclear medicine to the first class, the most serious. Mechanisms in defective tomographs prevent uncontrolled movement of the detector. Problems can lead to the fact that the suspended mass of the detector can fall on the patient.

Discovery NM (CT scanner)

If the 550kg detector falls, it can crush or clamp the patient. GE HealthCare has received eight complaints related to the issue, with no injuries or deaths reported as of Feb. 17, 2023. The recall includes a number of models of the 600/800 series nuclear medicine systems. These include the Brivo 615, Discovery NM 630 and Optima 640 devices. At the same time, the response also applies to the Discovery NM/CT 670 DR, 670 ES, 670 Pro and 670 CZT models. The recall includes the NM 830 and 830 ES models, as well as the NM/CT 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR and 870 ES.

GE Healthcare distributed defective systems between April 1, 2018 and December 16, 2022. She began the recall on Dec. 18, 2022, and on Feb. 17, 2023, recalled 688 devices in. The first USA FDA risk comes from a ball screw that softens the detector's suspended mass, it said. Some devices also lack a security key that should prevent the detector from falling catastrophically when the ball screw fails.

GE Healthcare's nuclear medicine systems allow you to assess diseases, injuries, anomalies and disorders. They create body images to help healthcare professionals assess organ functions or detect and diagnose diseases, disorders and cancer.

GE Healthcare sent an urgent letter to customers to correct medical device deficiencies to inform them of the issue. In the letter, the company recommended that customers stop using affected systems until GE Healthcare's service professionals conduct a review.^[1]

Notes