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.
Notas adicionales en la data
Causa
The ca-1500 series can develop micro holes by mechanical wear in the curved part of the sample arm tubing. the mechanical damage could be the result of a gradual wear out process especially on systems with a high workload or they might occur if the installation during a tube exchange is executed without a specific orientation of the tube bending and the appropriate fitting to the mechanics of the ca-1500 analyzer.
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.
Notas adicionales en la data
Causa
Manufacturer has become aware through a customer complaint that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024 and the wizard2 gamma counter scans the affected barcode label the protocol associated with barcode id #024 is executed. if the error is undetected the wizard2 gamma counter may produce erroneous results.
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.
Notas adicionales en la data
Causa
Smith & nephew inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. the current hip prostheses ifus do not provide adequate instruction on the revision surgeries due to ceramic failure. the ifu does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.
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.
Notas adicionales en la data
Causa
There is a potential error which was identified in the accu-check connect diabetes management app up to version 1.0.13 on ios. the error could lead to slow/interrupted data transfer between the accu-check aviva connect meter and the accu-chek connect app for ios.
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.
Notas adicionales en la data
Causa
Affected lots of edi's drugs of abuse tests have shown reduced reactivity for up to three (3) of the nineteen (19) benzodiazepine compounds for which specificity information is provided in the product insert. specific compounds for which there may be reduced reactivity include clonazepam nordiazepam and lorazepam. the test continues to perform as expected for other drugs.
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.
Notas adicionales en la data
Causa
The flash disk may cause the system to lock up with greater than expected frequency.
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.
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.
Notas adicionales en la data
Causa
In 1986 at the request of csa stockert installed a protective screen at the forward ventilation opening of c.A.P.S. roller pumps. it has been reported that the screen came in contact with printed circuit board.
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.
Notas adicionales en la data
Causa
Provide important new information regarding overinfusion associated with the synchromed ii implantable pump.Overinfusion is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs it will result in a volume discrepancy at pump refill where the volume withdrawn from the pump is less than the volume expected. overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk medtronic is not recommending prophylactic replacement of pumps.
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.
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.
Notas adicionales en la data
Causa
The use of a defective refa8 amplifier in combination with an accessory that would also be defective may pose a safety hazard that is only present in the case of invasive measurements.
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.
Notas adicionales en la data
Causa
Ground path on the workstation mounting bracket is suspect. single fault conditions exist that could energize the mounting bracket resulting in a noncompliance with regulatory requirements.
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.
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.
Notas adicionales en la data
Causa
Issue #1: when a single contour is saved in edit mode tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. this occurs when using the save button exit button or sendtolaser button. issue #2: when the region of interest (roi) is displayed on the beam's eye viewer (bev) in outline mode and the roi color is changed the color is changed in the multi-planar projection (mpr) viewers but not the bev viewers. issue #3: tumor loc-created datasets are flipped and incorrectly labeled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip minip or avgip). if the clinician obtains a clinical intensity projection dataset in a certain manner a dataset can be generated that is flipped left to right. the resulting dataset is flipped and incorrectly labeled left-to-right when displayed in a viewer.Issue #4: duplicate region of interest (roi) or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix " copy". this duplication can be created when creating a new isocenter or roi then creating another new isocenter or roi and naming the second isocenter or roi "firstname copy" (either manually or by clicking copy on the first isocenter or roi) where "firstname" is the name of the first isocenter or roi. if the user then selects the first isocenter or roi and clicks copy the resulting copy has the same name as the second isocenter/roi: "firstname copy".
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.
Notas adicionales en la data
Causa
Two lots of screws were commingled. specifically screws with etching and machining for lot number 62629432 (pn 00-4840-020-00) were packaged in bags labeled for lot number 62628759 (pn 00-2347-022-14) and screws with etching and machining for lot nuber 62628759 (pn 00-2347-022-14) were packaged in bags labeled for lot number 62629432 (pn 00-4840-020-00).
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.
Notas adicionales en la data
Causa
Five kit lots of product were incorrectly labeled with a date that extends past their 18 month expiration.
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.
Notas adicionales en la data
Causa
Monitoring of vitek's product by biomerieux detected elevated mic results. may cause category interpretations to shift towards more resistant results when an organism has a mic near the interpretive breakpoints.
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.
Notas adicionales en la data
Causa
One user found reduced zone sizes with batch 362701 of the cefpodoxime/clavulanate combination disc were observed when compared with isolates from same patients.
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.
Notas adicionales en la data
Causa
Ct transcatheter aortic valve implantation (ct tavi) planning applicationsupplied as an option to intellispace portal software version 6 may display incorrect measurements of cardiac and aortic anatomy. clinicians use this information to plan tavi procedures and to select and size the transcatheter heart valve (thv) to be used in the procedures.Reliance on incorrect information could contribute to an unsuccessful thv implantation procedure.
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.
Notas adicionales en la data
Causa
Some suction valves of the affected lot numbers may contain a component with dimensional discrepancy which may cause sticking during an endoscopy procedure. this recall was initiated because through internal review medivators has identified an increasing trend in occurrence rate of a situation where defendo suction valves were sticking during and endoscopy procedure. the complaints regarding potential sticking of defendo suction valves do not pose any additional risk of injury to device users or patients. in worst case conditions sticking of valves could result in a delay of the ongoing endoscopy procedure.
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.
Notas adicionales en la data
Causa
Following a study conducted on etest? polymyxin b with 180 clinical strains (pseudomonas aeruginosa acinetobacter and enterobacteriaceae) an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest? polymyxin b results are interpreted using clsi breakpoints.
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.
Notas adicionales en la data
Causa
The device displayed an "internal error reset required" message and executed a system reset. this could occurr while monitoring patients or may enter a continuous "system reset" loop.
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.
Notas adicionales en la data
Causa
Company became aware of reports of stent row separation between upper two rows of nitinol frame.
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.
Notas adicionales en la data
Causa
1. the previously health canada approved class ii medical device licence for the igea fast bone growth stimulator expired on oct 102016 and was not renewed by the manufacturer. 2. the labelling on the individual components within the system do not have product identifiers and do not meet the standards of a class ii device.
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.
Notas adicionales en la data
Causa
When images are acauired with a handswitch sporadic interruption of the x-ray beam may occur.