High FDA (Devices)·Z-0466-2013·Announced 2012-12-12

Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table

Philips and Neusoft are recalling 45 CT scanners because the patient table top can detach from the carrier, posing a risk of injury.

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 structural defect in a medical device that poses a risk of physical harm (falling table) to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Philips and Neusoft Medical Systems Co., Ltd. are recalling 20 units of the NeuViz 16 Multi-Sliced CT Scanner System and 25 units of the NeuViz Dual series CT Scanner System. The recall was initiated because the four screws that secure the patient table top to the carrier may pull out, causing the table top to detach.

The affected units were distributed nationwide, including in North Carolina, Ohio, Texas, and Puerto Rico. The specific serial numbers for the NeuViz 16 systems are N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, and N16E120024. The serial numbers for the NeuViz Dual systems are 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.

Healthcare facilities should contact the recalling firm to arrange for the necessary repairs or replacements to ensure the patient table is securely attached.

The recalled product

Product: NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 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 and det
Manufacturer: Philips And Neusoft Medical Systems Co., Ltd.
Category: Medical Device — CT Scanner
Hazard: structural-defect
falling-object

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)

NeuViz 16 system Serial numbers: N16E090002
N16E090003
N16E090004
N16E090007
N16E090008
N16E090010
N16E100015
N16E100017
N16E100023
N16E110016
N16E110023
N16E110026
N16E110027
N16E110040
N16E110053
N16E120016
N16E120022
N16E120020
N16E120023
N16E120024. Neuviz Dual Serial numbers: 400562

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Philips And Neusoft Medical Systems Co., Ltd.

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Same hazard · structural defect