Device Recall GEMINI GXL 6, 10 & 16 Computed Tomography XRay Systems, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61359
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1368-2012
  • 사례 시작날짜
    2012-01-26
  • 사례 출판 날짜
    2012-04-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, x-ray, tomography, computed - Product Code KPS
  • 원인
    Tumorloc will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. in tumorloc, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the organ list.
  • 조치
    Philips sent an Urgent - Medical Device Correction letters to all affected customers. The letter identified the product, what the problem is and under what circumstances it can occur, important information for the continued safe and proper use of the affected equipment, and actions to be taken to minimize the effect of the problem. Philips instructed their customers to put a copy of the letter with their "Instructions for Use" manual. For question contact your local Philips representative or local philips healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site Id or follow the prompts).

Device

  • 모델명 / 제조번호(시리얼번호)
    Model # 882390, Serial # 4001, 4012, 4013, 4016, 4021-4023, 4025, 4034, 4038, 4042-4044, 4049, 4052-4054, 4059, 4062, 4074, 4081, 4086, 4092, 4098, 4100, 4103, 4119, 4120, 4124-4126, 4129, 4133,4135, 4142, 4153, 4154, 4157, 4159, 4161, 4163, 4164, 4166-4169, 4171, 4176, 4178, 4181, 4182, 4184, 4187, 4190, 4192 & 4196-4198.  Model # 882400, Serial # 4006, 4047, 4075, 4093, 4110, 4121, 4134 & 4138.  Model # 882410, Serial # 4003, 4004, 4007-4011, 4014, 4015, 4018-4020, 4024, 4026-4033, 4035-4037, 4039, 4040, 4041, 4045, 4046, 4048, 4050, 4051, 4055-4058, 4060, 4061, 4063-4073, 4076-4080, 4082-4085, 4087-4091, 4094-4097, 4099, 4101, 4102, 4104-4107, 4109, 4111-4117, 4122, 4123, 4127, 4128, 4130-4132, 4136, 4137, 4139-4141, 4143-4152, 4155, 4156, 4158, 4160, 4162, 4165, 4172-4175, 4177, 4179, 4180, 4183, 4185, 4186, 4188, 4189, 4191, 4193-4195, 4199, 4201-4206, 7421 & G-10.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY. Product was also shipped to the following countries: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakstan, Kenya, Kuwait, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom & Venezuela.
  • 제품 설명
    GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by: Philips Medical System, Cleveland, OH || Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:  The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.  The detection, localization, and staging of tumors and diagnosing cancer patients.  Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA