Events

Recall of BV Endura R2.2 Mobile Xray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

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
    49605
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2011
  • Event Initiated Date
    2008-09-05
  • Event Date Posted
    2010-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73917
  • 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
    Mobile X-ray system - Product Code JAA
  • Reason
    Reliability of the stand-trolley cable may result in loss of images on the monitor during an examination. this intermittent problem can lead to system lock-up, where no radiation is possible and images are not visible on the monitor.
  • Action
    On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.

Device

BV Endura R2.2 Mobile Xray system
  • Model / Serial
    127 units are identified with Site Numbers:  544982, 546114, 546792, 546793, 547164, 548598, 548686, 548983, 549986, 549987, 550126, 550127, 550281, 550409, 550838, 550959, 551127, 551274, 551492, 551525, 551589, 551695, 551730, 552376, 552393, 552394, 552398, 552444, 552467, 552468, 552669, 552990, 553098, 553171, 553271, 553860, 553917, 553976, 553989, 554350, 554363, 554497, 554507, 554658, 554779, 555001, 555021, 555243, 555395, 555463, 555517, 555821, 556135, 556171, 556192, 556202, 556215, 556531, 556587, 556608, 556612, 556678, 556862, 556947, 556977, 556979, 557037, 557063, 557147, 557510, 557520, 557590, 558233, 558237, 558613, 558868, 558975, 559070, 559663, 559665, 41416327, 41443832, 41443860, 41445126, 41445430, 41445445, 41445552, 41445931, 41446303, 41566246, 41585083, 41630870, 41658558, 41661638, 41765654, 41796621, 41905206, 41938039, 41955473, 41957114, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42472756, 42551956, 42608281, 42639034, 42824768, 42861875, 42869100, 42880805, 42966787, 43181969, 43209307, 43209310, 43341471, 43453560, 43618928, 43618930, 43721228, 43722015, 45050110, and 45149708.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA