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
Precautions have been added to the instructions for use indicating additional information regarding the placement of a 4.1mm diameter trabecular metal implant in mandibles with dense (type d1) thick inferior border. this follows a complaint where the apical tip of a 4.1mmd implant separated from the implant during surgery.
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 affected eclipse versions user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. eclipse calculates dose for each field in a treatment plan and when all fields are calculated dose is summed and displayed to the user. if a treatment plan has been saved then reloaded from the database for additional planning activities user repositioning of mlc leaves may not invalidate or "clear" the calculated field dose. this condition is a result of how items are loaded into memory and subsequently handled for efficiency memory use when fields and mlc are saved and then recalled from database system defaults specify that objects may be unloaded from memory if 90% of available resources are consumed or as a periodic system maintenance task when the application is open for longer than 12 hours. in the rare instance that an mlc "object" is unloaded from memory due to one of these conditions the dose for that field will nolonger be conditional to the state of the mlc. in this case a change in the mlc leaf positions would not cause the field dose to be invalidated. this may go unnoticed if another field in the plan is not calculated and the total dose is not currently dislayed to the user.
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 the calibration panel it is possible for "superuser" and "field service engineer" user types to disable the front and back jaw potentiometer interlock. no procedure requires the interlock to be disabled.
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
Patient side cart battery boxes (bpm) returned from the field revealed that in some rare charging conditions the battery can overheat. overheating has the potential to result in the battery bulging and the release of internal battery gases into surrounding air.
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 has identified an issue with insufficient weld penetration which joins the shaft tube and blade tip. this may cause the blade tip to separate from the tube shaft during use.
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
Lack of sterility in products labelled sterile & manufactured since 1999 by rocket usa/a & a medical/lifequest georgia usa(ref. fda alert/march 14 & hc alert/march 22 2002).
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 potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan. there have been no injuries reported as a result of this issue.
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 identified the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
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 wide-volume scanning is performed in prospective cta or target cta studies with ecg gating unnecessary intervals may be set before starting the volume scan.
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 to address a potential issue where the buffer device component could incorrectly process the footswitch signal if power to the component device was lost through the manual tripping of a breaker. the incorrectly processes footswitch signal even though there is no operation interaction would potentially allow the laser to commence firing.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
The symbiq pump touchscreen may not respond to user selection may experience a delayed response or may register a different value from the value selected by the user. failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery of medication if the user does not confirm the intended programmed values on the pump'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.
Notas adicionales en la data
Causa
The median for the reference range with current kit lots differs from the guidelines published in the instructions for use.
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
Streptex latex gp a 50tst/kt - r30950601 lot 1929363 has an incorrect remel label expiry date of 08/31/2018 as listed on the outside of the box. the correct expiry date is 08/2017 as listed on the unit label on the product.
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
Individuals attempting to remove a lancet from the onetouch delica lancing device without following the instructions for use may experience an accidental needle stick. in addition over tightening of the cap may cause the needle to be exposed after firing which could also result in an accidental needle stick.
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 identified multiple issues with advia centaur xpt system software versions v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) v1.0.3 (bundle 1.0.1108 smn 11220781) and v1.1 (bundle 1.1.243 smn 11221979). these issues may affect the results generated by the system and are described below: 1. sample tip error 2. daily maintenance 3. result reporting for high/low linearity samples 4. auto-repeat conditions 5. barcode misreads in rack id mode 6. low probe wash 7. las communication 8. system status unknown.
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 complaints regarding the coat-a-count direct androstenedione assay demonstrating a higher frequency of results >10 ng/ml (>25 nmol/l) compared to alternate platforms.
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
Medtronic is communicating to paradigm pump users health care professionals and the certified pump trainers about the following three issues and proactively inform customers on how to avoid and mitigate these issues. 1.Users having experienced issues with the drive support cap of the pump: the insulin pump's drive support cap holds the pump motor in place and allows the motor's piston to press against the reservoir to deliver insulin. some users have experienced a loose drive support cap and in rare cases the cap may protrude from the bottom of the reservoir compartment. 2.Potential pump damage due to accidental exposure to water: as explained in the pump user guide exposure to water may result in pump alarm damage of the pump's internal electronics or cause the buttons to stop working. although it is unlikely that water damage will occur if an insulin pump is splashed or briefly dunked it should not be immersed in water. 3.Sensor graph timeout on the veo insulin pumps only: this information applies only to paradigm veo (mmt-554 and mmt-754) pump users who are also using medtronic continuous glucose monitoring and have the low glucose suspend feature enabled. the factory default setting for sensor graph timeout is set to 2 minutes. if the sensor graph timeout is set to "none" it can prevent the auto-resume of basal delivery 2-hours after a low glucose suspend event which can result in elevated blood glucose values. this will only happen if the pump user goes to the sensor graph screen during a low glucose suspend event and leaves that screen displayed.
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
Hp is expanding the recall because the mfr of the electrodes recently notified its customers including hp that the deterioration of the electrodes is not limited to the lots previously included.(rc16259).
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
Under certain conditions enclosure leakage current exceeds allowed limits. the measured enclosure currents can be 8 - 10ma. maximum allowed value for enclosure leakage current for single fault condition is 0.5ma according to iec60601-1:2005.
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 welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged and 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
1.Control result not marked as a control test: bayer healthcare has received user reports on contour next control test results that are higher than the control range published on the packaging of contour next test strips and not recognized as control tests by the meter. all lots of contour next control solution (levels low normal and high) are affected. 2.Control result outside of control range: another issue may affect any control solution lots when used with contour next test strip lots with expiration dates through november 2016. due to unforeseen material variation lots of contour next control solution may give control test results that are outside of the assigned control range as published on the packaging of contour next test strips. these control results are properly marked as control tests by the meter therefore this issue does not impact insulin 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.
Notas adicionales en la data
Causa
Smiths medical is recalling all level 1 normothermic iv fluid administration sets equipped with the f-50 gas vent filter assembly (gvfa) from the market and temporarily suspending all sales of these products because of complaints of kinking of the tubing and leaking of the f-50 gvfa. in some cases kinking in the tubing or leaking of the f-50 gvfa can cause a decrease in fluid flow rate.
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 error in eclipse appears when multiple carriage group dynamic mlc fields are generated from a plan that has had its primary reference point deleted.