Events

Recall of MultiDiagnost Eleva

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
    57777
  • Event Risk Class
    Class 2
  • Event Number
    Z-1656-2011
  • Event Initiated Date
    2010-10-07
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97393
  • 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
    x-ray system - Product Code IZI
  • Reason
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Action
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.

Device

MultiDiagnost Eleva
  • Model / Serial
    505345, 505346, 506236, 530589, 530777, 532140, 532151, 532213, 532703, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539598, 539990, 540252, 541263, 543272, 544059, 545014, 545156, 545198, 545841, 546031, 546578, 549417, 551519, 551714, 553287, 553435, 553838, 554283, 554284, 554633, 554640, 556197, 556369, 557258, 41444651, 41445097, 41445127, 41445131, 41445221, 41445237, 41445464, 41445652, 41445800, 41445927, 41455927, 41643223, 41783749, 41849575, 41954854, 42549980, 42799914, 42892004, 42892024, 42892425, 43319037, 43386703, 43443091, 43453378, 43721197, 44146025, 44401636, 44653739, 44654723, 45629333, 47130091, 47190569, 47413010, 47607148, 47783855, 49136896, 49144094, 49903432, 50003342, 50037841, 50416595, and 51599597.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed through out the US.
  • Product Description
    Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114.
  • 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