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
This voluntary field corrective action is being taken on the formula family of hemodialysis machines following reports of three thermal events which led to fire involving three different machines in the field. no patients or healthcare providers were injured as a result of these events. preliminary investigations indicate that the battery charge board was the source of two of the events. due to extensive damage on the machine the source of the third event is difficult to conclude. investigation into the trigger for the events is on-going. this recall involves all machines manufactured and imported since 1998. the corrective action will involve disconnection of the battery charge board to eliminate the possibility of the failure mode while a permanent solution is implemented.
Model Catalog: IBFTBD301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXMX310 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXMX301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXMX700 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFPBD301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFPBX301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFPBX310 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFPBX37D (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXBX700 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXBX301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXBX310 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXBD310 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXBD301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXMD301 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFPBD37D (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFXMD310 (Lot serial: ALL SERIAL# IMPORTED); Model Catalog: IBFTBX301 (Lot serial: ALL SERIA
제품 설명
FORMULA THERAPY DOMUS;FORMULA;FORMULA 2000 PLUS DOMUS;FORMULAR 2000 PLUS;FORMULA 2000;FORMULA 2000 DOMUS;FORMULA DOMUS;FORMULA THERAPY