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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Manufacturer has received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determined the root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly the spring arm of the lighting system can descend over time and eventually fall from the central axis. when the snap ring has been installed properly the potential for the lighting system to fall does not exist.
Model Catalog: 1510-2 (Lot serial: All lots); Model Catalog: T300 (Lot serial: All Lots); Model Catalog: 337556 (Lot serial: All lots); Model Catalog: 1500 (Lot serial: All lots); Model Catalog: 1510 (Lot serial: All lots); Model Catalog: 337547 (Lot serial: All lots); Model Catalog: 337541 (Lot serial: All lots); Model Catalog: TE300H (Lot serial: All Lots); Model Catalog: TE551-2 (Lot serial: All Lots); Model Catalog: TE330 (Lot serial: All Lots); Model Catalog: 337542 (Lot serial: All lots); Model Catalog: 337618 (Lot serial: All lots); Model Catalog: 1331 (Lot serial: All lots); Model Catalog: 1430 (Lot serial: All lots); Model Catalog: 337540 (Lot serial: All lots); Model Catalog: 337550 (Lot serial: All lots); Model Catalog: 1340 (Lot serial: All lots); Model Catalog: 1310 (Lot serial: All lots); Model Catalog: 1300 (Lot serial: All lots); Model Catalog: 1330 (Lot serial: All lots); Model Catalog: 1320 (Lot serial: All lots); Model Catalog: T510-2 (Lot serial: All Lots); Model Catalog: T510 (Lot serial