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
During the continuous post market surveillance of our fx cordiax dialyzers we have observed an increased number of cases of hypersensitivity and hypersensitivity-like reactions with the application of the fx cordiax dialyzers including life threatening events. these reactions occurred mainly both in the first treatment hour and within the first weeks of treatment with the fx cordiax dialyzers. the symptomatology varies and includes: dyspnoea chest congestion bronchospasm respiratory arrest hypotension tachycardia urticaria erythema flushing angioedema ocular hyperaemia pruritus abdominal pain nausea convulsions and unconsciousness.
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 complaint from a client intelerad is taking a pro-active field action to prevent occurrence of a possible patient safety problem at client sites. the issue is triggered by the presence of the "less than" character (<) in the report. when viewing a report the "less than" character is not present while it was there in the original report received by intelepacs. in other cases when the character is present in a combination with other characters parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.
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
Teleflex medical is recalling the hudson rci sheridan/cf cuffec tracheal tube due to a labelling inconsistency. teleflex medical has received complaints that the labelling of units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5 mm tracheal tube.
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
Device may be potentially subject to printed circuit board damage which can result in the monitor reporting spo2 values slightly outsied the normal accuracy range in operations manual.
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
Philips discovered that some welding joints on the vertical carriage brackets of the tube stand may crack. as a result the tube arm assembly may exhibit uncharacteristic sideways movement with the tube becoming off center. if all of the welding joints cracked the tube arm assembly could fall down.
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 barcode on the label of the clean solution vials provided in the liaison xl cleaning tool kit are not being recognized by the barcode reader of the liaison xl instrument. as a consequence the cleaning procedure does not start.
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
Beckman coulter has determined that the navios flow cytometer instructions for use (ifu) states that when a drip chamber level warning occurs the instrument will acquire for at least 5 minutes longer after the drip chamber level warning message is displayed. however the system may only acquire for as little as 3 minutes after the drip chamber level warning and will provide drip chamber level error. at that time the instrument will abort acquisition and does not save the listmode file and data are lost.
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 has been an increased number of invalid runs due to controls outside the package insert range with lot 29506m100. control results outside the package insert range would result in an invalide run.
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
Lot hp1115 may give a weak false positive line with no h. pylori antigen present making interpretation of test results more difficult than with previous batches.
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
External packaging of lot 04p1017a was mislabeled. incorect expiration date was placed on the external label indicating a three-year rather than one year expiration date.
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
Potential problem with the orientation labels on the post-processing chart when patients are imaged on their stomach (posterior-anterior).
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
To corect software errors in usr program selecto and image rotation.
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 ct number may shift due to a problem in the processing circuit for the data used to correct variations in the x-ray intesity resulting in changes to the contrast density of images.
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
Incorrect head movement and message display due to software errors.
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
Adapter with manufacturing defects could let ambient air enter the measuring chamber.
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
Siemens is issuing a customer notification for advia centaur t4 assay for the manual 1:4 and 1:8 dilution recovery used on advia centaur and advia centaur cp systems. percent recoveries for 1:4 (with calibrator 'a' prior to lots ending in 87) and 1:8 (all lots) patient sample dilutions are lower than reported in the ifu. a similar shift between calibrator 'a' and the internal standardization for t3 assay was also identified.
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
If sync mode is enabled and the device is switched from manual to aed mode there may be a delay in the delivery of energy to the patient for certain types of shockable ryhthms.
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
An important safety notice is being distributed to c.Cam customers with systems. the solution described in the letter is to update the c.Cam system chair per the update instruction mi007/07/s.
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
Potential malfunction and hence hazard to patients when using syngo imaging version lines vb20 vb30 vb35 in combination with ris (radiology information system) that is violating dicoms (digital imaging and communication in medicine) standard by creating non-unique study instance uids (unique identifier).
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
This update instruction will help to recognize faulty gradient cable connections and subsequently prevent those from overheating. as part of the ui thermal sensors (self-adhesive labels) will be attached to the connections identified as critical.
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 certain cpr meters shipped as part of the q-cpr option of the heartstart mrx monitor/defibrillator (m3535a/m3536a) the force measurement sensor in these cpr meters can gradually lose sensitivity with use. this can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression.
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
Siemens is advising customers of a change in qc values for the thermo scientific mas cardioimmune xl control lot 1601 level 1. the manufacturer of the controls notified siemens of changes to the control product after the qc values were published and as a consequence the values provided with the dimension n-terminal pro-brain natriuretic peptide flex reagent lots ga4210 fc4168 fa4098 and fa4224 require revision.
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
A smell of burning/smoke is emanating from the x-ray generators. this is caused by a failed printed circuit board electronic component and an internal electronic transformer. these failures will cause the generator to become inoperative.
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 received reports of no flow through the ops valve. this is a follow-up activity associated with a prior safety alert dated july 2017.