Agency classClass IIOur severity:High FDA (Devices)·Z-3045-2017·Announced 2017-09-06

Neusoft NeuViz 128 CT Scanner Software Defect Recall

Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.

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 is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or structural defects fall into the High severity category, representing a risk of harm where injury has not yet been reported or is remote.

Plain-English summary

Neusoft Medical Systems Co., Ltd. is recalling 154 units of the NeuViz 128 Multi-slice CT Scanner System. These devices are used as whole-body computed tomography X-ray systems that reconstruct cross-sectional images of the body. The recall covers systems equipped with software version 1.0.7.4038+P16 or any previous version.

The recall was initiated on May 19, 2017, and was mandated by the FDA. The reason for the recall is a software defect. The agency classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected units were distributed nationwide in the United States. The recall status is currently terminated, with a termination date of November 19, 2020. Initial notification to facilities was sent via letter.

The recalled product

Product: Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is…
Manufacturer: Neusoft Medical Systems Co., Ltd.
Category: Medical Device — Imaging Equipment
Hazard: software-defect
Affected units: 154

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Neusoft Medical Systems Co., Ltd. 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 2 products in this recall →

Same manufacturer · Neusoft Medical Systems Co., Ltd.

See all →

Moderate
Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
FDA (Devices) · 2019-05-29
Moderate
NeuViz 16 Essence CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
Moderate
Neusoft NeuViz 128 CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
Moderate
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
Moderate
Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04

Same hazard · software defect