Events

Recall of Device Recall Brightview X

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
    76483
  • Event Risk Class
    Class 2
  • Event Number
    Z-1481-2017
  • Event Initiated Date
    2017-01-31
  • Event Date Posted
    2017-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153340
  • 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
    nuclear medicine diagnostic scanner - Product Code KPS
  • Reason
    Four issues: 1. motion controller problem stops scan and no data image produced. 2. door interlock switch problem disables ct scan. 3. detector contacts head holder when performing patient unload. 4. jetstream freezes during gated planar scan.
  • Action
    Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.

Device

Device Recall Brightview X
  • Model / Serial
    11000100, 11000019, 11000034, 11000020, 11000112, 11000086, 11000045, 11000092, 11000037, 11000038, 11000106, 11000059, 11000064, 11000039, 11000087, 11000004, 11000058, 11000030, 11340005, 11000113, 11000117, 11000011, 11000118, 11000074, 11000075, 11000036, 11000104, 11000103, 11000071, 11340002, 11000089, 11000012, 11000041, 11000042, 11000043, 11000049, 11000014, 11000099, 11000022, 11000031, 11000005, 11000028, 11000073, 11000040, 11000077, 11000008, 11000048, 11000093, 11000096, 11000097, 11000069, 11000079, 11000080, 11000024, 11000076, 11000085, 11000108, 11000109, 11000115, 11000056, 11000029, 11340003, 11000044, 11000107, 11000090, 11000017, 11000110, 11000009, 11000035, 11000081, 11000062, 11000013, 11000015, 11000063, 11000083, 11000091, 11000098, 11000054, 11340004, 11000102, 11000061, 11000095, 11000023, 11000094, 11000060, 11000055, 11000070, 11000084, 11000088, 11000068, 11000052, 11000057, 11000050, 11000067, 11000007, 11000010, 11000027, 11000032, 11340001, 11000026, 11000114, 11000078, 11000051, 11000046, 11000003, 11000018, 11000066, 11000047, 11000101, 11000065, 11000072, 11000116, 11000016, 11000105, 11000025, 11000006, 11000033,
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.
  • Product Description
    882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA