Events

Recall of Device Recall SKYLight

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

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
    57589
  • Event Risk Class
    Class 2
  • Event Number
    Z-1551-2011
  • Event Initiated Date
    2010-12-28
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96730
  • 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
    Emission Computed Tomography System - Product Code KPS
  • Reason
    Philips healthcare nuclear medicine determined that the detector arm assembly could be compromised.
  • Action
    Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.

Device

Device Recall SKYLight
  • Model / Serial
    Catalog number 882050;  Model number (8 FT 3/8): 2161-3000A, Serial numbers: K03100064 K03100065 K04120121 K04120122 K03050033 K03080053 K03080054 K03090055 K03090056 K03090057 K03090058 K03090059 K03090060 K03100061 K03100062 K03100063 K04010069 K04010070 K04010074 K04020072 K04020073 K04020074 k04030076 K04030075 K04030077 K04030078 K04030080 K04040081 K04040082 K04040083 K04040084 K04050086 K04050087 K04050088 K04060089 K04060090 K04070099 K04080100 K04080101 K04080102 K04090103 K04090104 K04090105 K04090108 K04090109 K04100110 K04100111 K04100112 K04110113 K04110115 K04110116 K04110119 K04120120 K04120123 K04120124 K04120125 K04120126 K04120120 K04120120.  Model number (9 FT 3/8); 2160-3000A; Serial Numbers: K03080136 K03090138 K03100140 K03100142 K03110143 K03110144 K03110145 K03110146 K03110147 K03120148 K04010150 K04010152 K04010153 K04030155 K04030157 K04030158 K04060166 K04060167 K04070168 K04070169 K04070170 K04080172 K04090178 K04100183 K04100186.  Model number (8 FT 5/8): 2161-3001A; Serial numbers: K03020003.  Model number (9FT 5/8): 2160-3001A. 11131
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. || Philips Medical Systems || Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA