Events

Recall of GE Healthcare, Precison 500D Classical R&F; System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

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
    47235
  • Event Risk Class
    Class 2
  • Event Number
    Z-0274-2008
  • Event Initiated Date
    2007-08-01
  • Event Date Posted
    2008-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69080
  • 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
    Image-intensified fluoroscopic x-ray system - Product Code JAA
  • Reason
    Inaccurate cassette size display reading/ inaccurate mas reading: 1. when the device is in pbl mode and a larger film cassette is inserted into the table bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. the collimator stays at the original smaller cassette size and allows the operator to take an exposure.
  • Action
    Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.

Device

GE Healthcare, Precison 500D Classical R&F; System
  • Model / Serial
    Code Numbers:  00000003712M37 00000004383M36 00000004912M32 00000004207M37 00000003989M31 00000004669M38 00000004911M34 00000003192M32 00000003711M39 00000004391M39 00000003988M33 00000003101M33 00000003986M37 00000003899M32 00000003916M34 00000003991M37 00000003893M35 00000004385M31 00000003190M36 00000004208M35 00000003716M38 00000003918M30 00000003922M32 00000004577M33 00000004572M34 00000003792M39 00000004392M37 00000004388M35 00000004659M39 00000003407M34 00000004209M33 00000003992M35 00000004575M37 00000004579M39 00000003897M36 00000003913M31 00000004782M39 00000003404M31 00000003915M36 00000004389M33 00000003719M32 00000004660M37 00000004780M33 00000004212M37 00000004384M34 00000003896M38 00000003921M34 00000004386M39 00000003226M38 00000003224M33 00000003412M34 00000003386M30 00000004206M39 00000004215M30 00000003189M38 00000004781M31 00000003892M37 00000003713M35 00000004663M31 00000003715M30 00000003227M36 00000004665M36 00000003409M30 00000004787M38 00000003229M32 00000004416M34 00000003403M33 00000004786M30 00000003191M34 00000004578M31 00000004390M31 00000004785M32 00000003408M32 00000003987M35 00000004661M35 00000003894M33 00000003900M38 00000003383M37 00000004662M33 00000003793M37 00000004664M39 00000004909M38 00000003406M36 00000003901M36 00000003405M38 00000003895M30 00000003710M31 00000003717M36 00000004913M30 00000003898M34 00000004170M37 00000003718M34 00000003411M36 00000003919M38 00000003102M31 00000003225M30 00000003384M35 00000003387M38 00000003794M35 00000003917M32 00000003920M36 00000004213M35 00000004415M36 00000004417M32 00000004581M35 00000004666M34 00000004789M34 00000004916M33 00000004999M39 00000005000M35 00000005063M33 00000005064M31 00001009888WK7 00000003990M39 00000004210M31 00000004214M33 00000003993M33 00000004181M34 00000004414M39 00000004418M30 00000004574M30 00000004667M32 00000004668M30 00000004670M36 00000004784M35 00000004788M36 00000004910M36 00000005001M33 and 00000005070M38.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.
  • Product Description
    Precision 500D Classical R&F; System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA