Agency classClass IIOur severity:High FDA (Devices)·Z-1165-2013·Announced 2013-05-01

Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard

Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.

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 risk-of-harm product where a specific injury (finger pinch) has been reported, but the source does not indicate fatalities or serious injuries requiring hospitalization, fitting the 'High' severity criteria for reported injury without escalation to 'Severe' or 'Critical'.

Plain-English summary

Philips and Neusoft Medical Systems Co., Ltd. are recalling 23 units of the NeuViz 16 Multi-Slice CT Scanner System. The recall is due to a potential hazard where user error may cause personnel injuries. Specifically, a report indicated that a finger was pinched when the table was moved backward while the tabletop was being controlled by another person from the gantry left control panel.

The affected units were distributed nationwide in the United States, including California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico. The specific serial numbers for the recalled units are listed in the official recall documentation.

Healthcare facilities should stop using the affected NeuViz 16 CT Scanner Systems and contact the recalling firm for instructions on how to proceed with the recall.

The recalled product

Product: NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
Manufacturer: Philips And Neusoft Medical Systems Co., Ltd.
Category: Medical Device — Imaging Equipment
Hazard: pinch-injury
Affected units: 23

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: N16E090002
N16E090003
N16E090004
N16E090007
N16E090008
N16E090010
N16E100015
N16E100017
N16E100023
N16E110016
N16E110023
N16E110026
N16E110027
N16E110040
N16E110053
N16E120016
N16E120020
N16E120022
N16E120023
N16E120024

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 Dual CT Scanner Recalled for 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