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.
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원인
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.
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)
제품 설명
ZIPPIE IRIS WITH MONO BACKREST SYSTEM WITH DYNAMIC BACKREST