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 has received and confirmed complaints of elevated cortisol calibration slopes that are outside of the defined reagent lot specific calibration slopes when using cortisol reagents prior to the end of the reagent shelf life. when this occurs the system will flag the failed calibration of the assay and quality control and patient results can not be generated.
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
Philips has become aware that some pas-210 active speaker assemblies in use with the philips intellivue information center (piic) have experienced intermittent audio or loss of audio. after investigation it was determined that the speaker failures may delay recognition of an alarm condition if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system e.G. a bedside monitor. this may result in delayed treatment of the patient.
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
Mindray has received two (2) reports that the battery pack for the tl transport monitor /module overheated forming a small melted cavity in the outer housing. in both reports the battery emitted smoke and was hot to the touch. in one (1) report a small flame was noted on the battery surface.
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 problem found to calibrate theo in which an overy recovery of level 3 calibrator was observed and results may be outside acceptable calibration guidelines.
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
Beds contain linak control box that may be faulty and cause the box to stop functioning and cause the external circuit to become thermally charged.
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 leads of 5 lead cable have been cross connected.
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
Joerns healthcare has identified an issue with the incorrect bed model (easycare) etl/intertek label being applied to ultracare xt beds. the impacted beds were manufactured on september 8 2017.
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 alert on the potential risk of aneurysin rupture in patients implanted with the aneurx stent graft system and to provide patient care recommendations.
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
Rises in ventilator circuit pressure when used with the latest software release revision k.
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
Mindray has become aware of the potential for a software anomaly to manifest on the a-series anesthesia system. no adverse patient event was reported. this potential issue is related to the system's electrically erasable programmable read-only memory (eeprom) and will only occur if the system's total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case.It will not occur during a case.Two scenarios may occur resulting from this issue.1) the unit will not be able to enter standby mode when the user confirms "discharge" (in software bundle version < 02.06.00) or "end case" (in software bundle version > 02.06.00) in the dialog box. under these conditions the unit can only enter the standby mode by manually unchecking "restore default settings" in the same dialog box.When the "restore default settings" in the dialog box is unchecked the previous settings will be applied to the next case instead of the user established default settings.If left unaddressed for a period of time this second scenario will be encountered.2) at startup the unit will automatically skip over the startup leak test as well as standby mode and immediately enter either manual or automatic ventilation mode depending on the position of the manual/auto switch.This potential issue affects a-series systems with software bundle version 02.02.00 through 02.11.00 and some units with 02.11.01.
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 healthcare diagnostics received customer complaints regarding instabilities of high sensitivity c-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots.
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
L'utilisation du profil phenotypique inclus dans le coffret dans l'evaluation des reactions positives aurait produit des resultats discordants ou ambigus. il existe une possibilite de mal identifier les anticorps anti-jk(b) et -s et des problemes transfusionnels que cela aurait pu causer.
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 issue concerning unintended direction of gantry rotation during an auto-sequenced treatment delivery.
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 the main "order entry" screen and in the "analyzing" screen of the core lab module users can delete the priority for a test and leave the field empty or press the spacebar to only insert a blank space.
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 healthcare diagnostics has determined through an internal investigation that the assays listed do not align with the representative data published in the instructions for use (ifu) for onboard stability calibration frequency and/or interference. the assays that did not meet the obs and the calibration frequency ifu claims are: microalbumin_2 (ualb_2) alanine aminotransferase (altp5p) lithium (lith) alkaline phosphatase (alpamp) alkaline phosphatase (alpdea) magnesium (mg) magnesium concentrated (mg_c) total protein ii (tp) acetaminophen (acet) immunoglobulin g_2 (igg_2) transferrin (trf) total bilirubin (added to customer notification due to typographical error). the assays that did not meet the interference ifu claims are: alanine aminotransferase (alt) ammonia (amm) carbon dioxide liquid (co2_l) gamma-glutamyl transferase (ggt) high sensitivity c-reactive protein (hscrp) inorganic phosphorus (ip) inorganic phosphorus_concentrated (ip_c) lactate (lac) uric acid_concentrated (ua_c) wide range crp (wrcrp) lithium (lith) alkaline phosphatase (alpamp).
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
Holter software version 2.9 and 2.9.1 may contain problems which could affect its performance.
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 software calculation utilizes 17ul rather than 12 ul for the alkaline washing solution dispensed the displayed value for volume remaining will be less than the actual amount in the bottle.
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
Bd usa discovered that lot number 45602 of the bd procount progenitor cell enumeration kit (material no 340498) failed to meet internal stability specifications. failure of stability can result in poor resoluti.
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 timer used in the amalgamator had an undiscovered software issue that may allow the motor to run longer than the set timing value set on the potentiometer.
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
Advisory letter: im-maxx wedge treatment delivery with im groups.
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 dynamic conformal arc treatments(dcat) are planned with the beam modulator the closed leaves remain inside the open treatment area. when the closed leaf gap(minimum leaf separation) is set to 0mm on xio & the accelerator is set to a value other than 0mm xio will underestimate the dose delivered. no patients mistreated.
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 foil the urine bags are made of are sticking and does not allow the urine to flow into the bag.
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
Due to improper soldering in limited components of a specific production lot of large display bypass module (lot delivered from december 18 2014 to march 09 2015) a loss of video signal could potentially occur. this is not observed in the field and only sporadic cases are observed in factory screening.