High FDA (Devices)·Z-1166-2013·Announced 2013-05-01

Philips NeuViz Dual CT Scanner Recalled for Pinch Hazard

Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.

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 risk-of-harm product where a specific injury (finger pinch) has been reported, but the source does not indicate hospitalization or death, fitting the 'High' severity criteria for reported injury without severe outcomes.

Plain-English summary

Philips and Neusoft Medical Systems Co., Ltd. are recalling 25 units of the NeuViz Dual series CT Scanner System. The recall involves specific serial numbers distributed nationwide in the United States, including California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.

The recall was initiated because user error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. The source text notes a specific report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Users should follow the instructions provided by the recalling firm to mitigate the risk of injury.

The recalled product

Product: NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data ta
Manufacturer: Philips And Neusoft Medical Systems Co., Ltd.
Category: Medical Device — Imaging Equipment
Hazard: pinch-injury
Affected units: 25

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 (20)

Serial numbers: 400562
400563
400626
NDH009EI
NDH011EI
NDH012EI
NDH013EI
NDH016EI
NDH017EI
NDH026EI
NDH027EI
NDH028EI
NDH030EI
NDH031EI
NDH034EI
NDHR080001
NDHR080002
NDHR080003
NDHR080004
NDHR080007

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips And 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 · Philips And Neusoft Medical Systems Co., Ltd.

See all →

High
Philips NeuViz 16 CT Scanner Recall for Patient Data Error
FDA (Devices) · 2016-05-04
High
Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard
FDA (Devices) · 2013-05-01
High
Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table
FDA (Devices) · 2012-12-12
High
Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator
FDA (Devices) · 2012-08-01

Same hazard · pinch injury