Events

Recall of ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNRISE MEDICAL CANADA 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
    151672
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Sunrise medical (us) llc recently received two (2) complaints for the mono backrest system with the dynamic backrest option on iris wheelchairs where the back bolts broke and the mono backrest fell backwards.

Device

ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST
  • Model / Serial
    Model Catalog: EIZ5A (Lot serial: ZRS-042132 to ZRS-042751); Model Catalog: EIZ4-2 (Lot serial: IRS-046185 to IRS-063457); Model Catalog: EIZ4-2 (Lot serial: IRSE-058994 to IRSE-063928)
  • Product Description
    ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST
  • Manufacturer
    SUNRISE MEDICAL CANADA INC.

Manufacturer

SUNRISE MEDICAL CANADA INC.