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 recall is related to the under-recovery of lot number 604450-01 of tina-quant cardiac c-reactive protein (latex) high sensitive (cat# 11972855216) in human serum and plasma.
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
Villa sistemi medicali became aware that a patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and the table was moving from vertical position. the analysis showed that the footrest of the device detached from the table top because the safety screws were discarded at installation. the purpose of these screws is to prevent the footrest to completely detach from the table in order to avoid the patient to fall.
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
Dose calculations for arc fields using the pencil beam convolution with the generalized batho power law or modified batho heterogeneity correction methods can be wrong if the beam data contains xxx.Lih file.
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
Some customers were instructed to clean blades on caps rather than to replace them as specified in the maintenance instruction 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
A variation in flute depth on the listed routers was observed. the variation in flute depth may cause the routers to be more susceptible to breakages.
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
Olympus has initiated this recall after discovering that the endoeye distal end can become abnormally hot if the temperature sensor at the device's tip is damaged. although no customer complaints have been received referring to this issue and thus manufacturer is not aware of any patient or user injury excessive heating of the endoeye distal end could result in patient or user injury. to prevent a potential risk to patient or user health olympus is undertaking this action to repair the devices by disabling a specific feature on the video telescopes ("fog-free function") to prevent excessive heating of the endoeye distal end under certain conditions.
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 recall is related to a situation that due to a software limitation a measurement timing error could occur under specific conditions while using the cobas c111 (cat #04528778001) or the cobas c111 with ise (cat # 04777433001) analyzers.
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 laparoscopic insufflation tubing with filet (su-1101) is not licensed for sale in 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 manufacturer identified a defect in a limited number of the accessory (part#'s d800wpexpert and # d800wp both wall-mounting plates) which may cause the mounting screws to break loose resulting in the x-ray unit to fall.
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
Through investigatin biomet 3i determined that the provided protection caps (ppc***) and the provide impression copings (pic***) have not demonstrated adequate biocompatibility . in that the items were both found to elicit a cytotoxic response (grade 4).
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 service suresight vision screeners were calibratedand the that the calibration activity performed may not have returned the device to working order. in its current state the device will most likely not be able to take a reading or it may be very difficult to get a reading. devices affected are limited to those serviced between july 17 2015 and aug 7 2015 at the welch allyn skaneateles falls location.
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 in the process of obtaining medical device licence.Manufacturer has iso 134852003 however the certificate is issued by a registrar not recognized by health canada (not cmdcas).
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
Foot switch modification and sftware upgrade to prevent inadvertent c-arm motion and correct disagreement between actual and selected mas.
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 user leaves test plug in inspiratory flow sensor following low p leak check & therapy is initiated the machine is not capable of providing gas to the patient which could lead to hypoxia.
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 affected corometrics 174 units were delivered with the incorrect fecg port label. we have identified that the corometrics 174 series products may not currently meet type cf leakage testing requirements. the products do meet testing requirement for type bf leakage limits.
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 inform users about potentially false measurements when using the pressure input channel p4.
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 manufacturing process to package each tip cover each part is placed into the top open end of a rectangular pre-made pouch which is sealed along the sides and bottom edges. to seal the pouch containing the product the open end edge is clamped and sealed by applying heat and pressure creating a closed seal impressed with a thatched pattern. it has been found with a small number of the pouches manufactured when creating the closure the sealed edge was not uniform and pleats or creases were formed within the seal area of the pouch. of those non-uniform seals in a small percentage of these seals these pleats or creases may breach the seal barrier integrity.
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 performance shift was observed in the architect intact pth assay that has the potential to generate falsely elevated results on patient samples. results generated in a study using current in-date reagent and calibrator lots demonstrated a magnitude of shift relative averaging approximately 13% to 45% when compared to package insert data. the shift was observed across the full analytical range of the assay.
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 system phantom supplied with certain scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm 4mm 5mm 6mm 7mm and 8mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the ifu manual. however the pin visibility deteriorates over time usually a few years. this causes the test to become unreliable and inaccurate. to ensure that low contrast is within specification philips is providing instructions as a guideline to a more reliable check of the image noise on the water layer of the system phantom.
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 access hav ab assay of product lot exhibits inconsistent patient dose response. this inconsistency may be manifested by erroneously low or high qc/sample dose results that could cause incorrect qualitative classification (i.E. false positive false negative false equivocal results) for 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
Packages containing fg557 burs were mislabeled as la 5 burs.
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 reports have been received that the driver handle of the 5.5 mm crossft suture anchor has the incorrect color. it should be black but is red.
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
Eclipse oxygen system units may experience premature wear on electrical connector between battery bridge printed circuit board and power manager printed circuit board that could lead to temporary power interruption when operating from power cartridge causing unit to sound an alarm and shut 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
Abbott point of care has determined that while using specific non-blood sample types (hematocrit calibration verification control and hematocrit proficiency) certain lot and box numbers of i-stat cartridges may exhibit an increased rate of hematocrit (hct) suppressed results (star outs). in-house testing has confirmed that the hematocrit suppressed results are not observed in patient samples and results generated are within the expected performance range.