FDA Adverse Event
Malfunction
Summary report: N
NEUVIZ 16
MDR report key: 2033695
·
Received February 11, 2011
Report
- Report Number
- 3004761566-2011-00001
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 4, 2011
- Report Date
- February 9, 2011
- Manufacturer
- PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
- Product Code
- JAK
- PMA / PMN Number
- K092742
- Removal / Correction Number
- 3004761566-02/11/2011-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ACTION PLAN IS AS FOLLOWING: A FIELD SAFETY NOTICE WILL BE SENT TO ALL END USERS. MANDATORY FIELD CHANGE ORDER AND FCO KITS WILL BE RELEASED TO ALL AFFECTED SYSTEMS. THE MANDATORY FIELD CHANGE ORDER IS EXPECTED BY (B)(4), 2011. ALL AFFECTED SYSTEMS WILL BE UPDATED WITH AFOREMENTIONED KITS IN 6 MONTHS AFTER THE RELEASE.
Description of Event or Problem · 1
AN ISSUE WAS IDENTIFIED ON (B)(6) 2011. DIMENSION MEASUREMENT DISPLAYS ON A COMBINED IMAGE WERE FOUND INACCURATE AFTER THE CLINICIAN MERGED MULTIPLE IMAGE SERIES INTO ONE IMAGE. INVESTIGATION CONCLUDES THE PROBLEM MAY AFFECT ALL NEUVIZ 16 CT SYSTEMS. IF THE ISSUES WERE TO REOCCUR, THERE IS A POTENTIAL THAT APPLYING INACCURATE DIMENSION INFORMATION MAY CAUSE MISDIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUVIZ 16 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. | 989605858501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |