Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61359
  • Event Risk Class
    Class 2
  • Event Number
    Z-1368-2012
  • Event Initiated Date
    2012-01-26
  • Event Date Posted
    2012-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107894
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code KPS
  • Reason
    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.
  • Action
    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

Device Recall GEMINI GXL 6, 10 & 16 Computed Tomography XRay Systems,
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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