Events

Recall of BV Pulsera Rel 2

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
    50066
  • Event Risk Class
    Class 2
  • Event Number
    Z-2463-2010
  • Event Initiated Date
    2008-09-10
  • Event Date Posted
    2010-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74613
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    The c-arm rotation brake does not always function properly, and may not hold the c-arm position if the c-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. unwanted c-arm movement may cause the c-arm to collide with a patient. the brakes function properly if the c-arm is rotated to its maximum positions.
  • Action
    Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377

Device

BV Pulsera Rel 2
  • Model / Serial
    Devices are identified with Site Numbers:  505029, 506745, 522087, 533824, 536622, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543862, 543947, 544191, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544622, 544972, 544984, 545085, 545102, 545103, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546680, 546687, 546786, 546788, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547221, 547284, 547288, 547299, 547375, 547602, 547603, 547643, 547656, 547684, 547710, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548354, 548366, 548385, 548397, 548398, 548569, 548602, 548653, 548700, 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: Throughout the US.
  • Product Description
    Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
  • 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