Recall Z-0466-2013— Philips And Neusoft Medical Systems Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Philips And Neusoft Medical Systems Co., Ltd., initiated 2012-10-18, terminated 2013-07-08. It names 4 FDA 510(k) clearances: K092742, K090173, K071308 and 1 more. 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 detector array with multi-slice capability up to 16 slices simultaneously.. Reason: The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners..
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-18
- Terminated
- 2013-07-08
- Firm location
- Shenyang, Liaoning, N/A, China
510(k) clearances named in this recall
4 on FDA's record- K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K090173 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K071308 — MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- K062451 — NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 detector array with multi-slice capability up to 16 slices simultaneously.
Reason for recall
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Data sourced from openFDA. This site is unofficial and independent of the FDA.