Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Potentially inaccurate report of data by recomscan software.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The purpose of this letter is to provide you important safety information regarding the use of the depth stop
accessory provided in all medtronic deep brain stimulation (dbs) lead kits. the medtronic dbs depth stop,
otherwise referred to as the lead holder, is used to establish the implant depth. the depth stop interfaces with
parts of the stereotactic system used during surgery to control placement of the dbs lead tip to the target
location. this letter provides information regarding a product performance issue that has been identified with this
component, potential risk to patients, and actions to take regarding use of the medtronic depth stop.
if you do not use the medtronic depth stop (for example, if you only use the fhc, alpha omega, or nexdrive depth
stop), you are not affected and no actions are needed. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The purpose of this letter is to advise you that medtronic is recalling specific item codes and production lots of
covidien valleylab‘“ laparoscopic electrodes. this field safety corrective action (fsca) is being conducted due to
the potential for compromise of the package resulting in a breach of the sterile barrier. the use of products with
this packaging defect may increase risk of infection. there have been no reports of serious injury associated with
this issue.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
This communication is to
inform you of a voluntary recall of select lot numbers of the medtronic euphora™ and solarice™ semi-compliant
rapid exchange (rx) balloon dilatation catheter due to reports of difficulties in removing the stylette. availability of
each of these products will vary by geography. a summary of the model numbers and lot numbers affected by this
issue can be found in appendix a of this communication. the medtronic nc solarice™ and nc euphora™ non-
compliant rx balloon dilatation catheters are not affected by this issue.
the total number of customer reports relating to removal difficulties associated with this generation of medtronic
semi-compliant rx catheters represent 0.1% of all affected units manufactured and distributed (since 12 january
2017). medtronic has received one (1) report of patient injury related to this matter. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
This specific subset of stent grafts has greater susceptibility to fabric permeability
variations that may be associated with endoleaks observed during the initial implant
procedure. at the time of implant procedure this permeability variation may cause the
physician to categorize a type iv endoleak (which typically self-resolves over time) as
an acute type iii fabric endoleak because the leak may appear to be focal or a localized
leak as opposed to a diffused leak (blush). the misclassification as an acute type iii
fabric endoleak may lead to unnecessary secondary interventions.
the permeability variation is limited to a subset of 23mm and 25 mm devices that were
manufactured with specific lots of graft material. this recall does not affect any other
models or serial numbers of the endurant/endurant ii bifurcated stent graft systems. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Bioscot monoclonal control reagent is incorrectly classified as a non-annex ii “self-declared”
ivd product under 98/79/ec directive. this product will be re-classified and certified as an annex ii
list a product.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The purpose of this correspondence is to bring an it security vulnerability to your attention affecting
a machine type in use at your site which was discovered in the course of a penetration test carried
out by an it security expert. this only applies to machines which are actually connected to an in-
house network. all other machines are not affected and are therefore not at risk. the following
applies to machine in a network:
• in the event of an attack on the in-house network of a hospital, a laboratory or a surgery,
there is a risk that data from miele washer-disinfectors can be read out and/or replaced. this
data is for the most part binary code.
• theoretically, a hacker with criminal intent could attempt to make abusive use of this data in
order to obtain access to the programme controls and to manipulate these. if pursued to the
limit, hackers could even, after further data analysis and with a knowledge of instrument
reprocessing, try to falsify cycle records with a view to covering up manipulation. the same
applies to unauthorised actions on the part of persons with legal access to the appropriate
network.
• to date, there has been no evidence indicating that such an incident has ever occurred.
such targeted manipulation of data, as described above, would require considerable effort
and an in-depth knowledge of this highly specific machine software.
miele considers the risk of a hacker successfully carrying out the multi-stage manipulation described
above and causing a potential threat to the health of patients to be extremely low. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Millipore (uk) ltd is issuing this field safety notice for the bioscot anti-m monoclonal
blood grouping reagent lots identified in both tables 1 and 2 (the “product”). the product
lots detailed in table 1 are showing weak and /or negative results when testing m+ red blood
cells in line with the method described in the instructions for use (ifu).
the product lots detailed in table 2 have not displayed the same weak reactions at this time,
however millipore (uk) ltd have made the decision to include all lots of product code ne in
this field safety notice as a precaution.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Multiparametric magnetic resonance imaging of the prostate -
pi-rads pdf-report possibly shows wrongly numbered identifiers in the schematic
overview graphic of the prostate
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
We are contacting you regarding an incident report filed to the swedish medical products agency. the
incident concerned inaccurate programming ofan hma used for nutritional analysis ofhuman milk. the error
was found only at analysis on the instruments calibration for unhomogenized milk, where the protein levels
were overestimated.
miris takes this incident very seriously. without further investigation of each instrument we are unable to
rule out that no other instruments are also affected by the error, which may lead to incorrect nutrition of
preterm infants. therefore, miris recommends users to stop using the hma for fortification purposes in
nutritional care of pre-term infants until the instrument has been controlled and validated by miris
staff.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
On 25/01/2017 we received the request from our french supplier to recall the article mentioned below.
already on 12.12.2016 the same article was recalled. this call was affected by lots 510160625 and 510160628. the return call was completed quickly and successfully. there has been no incident with the products affected by the recall in germany.
for this second call, our sales force has again asked us to contact you and collect this item with the lot 510160810 for exchange into an unaffected lot number, if any.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Following notification of an incident of failure of an axial segment of a ceiling pendant component, mz liberec is initiating a field safety corrective action. our company will substitute all the axial segments in the field for the new ones. you should receive these new parts along with this notice. we have also increased the inspections of these components as part of the manufacturing process to prevent reoccurrence of similar incidents in the future. it is important that all users inspect the axial segment components for excessive wear. if the any part of the segment has a thickness of less than 1.7 mm, users should cease using the product immediately.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Natus medical has received feedback from some customers about early failure of the neoblue® blanket system
fiber optic pads. these failures involve discoloration/degradation followed by eventual melting of the fiber optic
bundle at the connector that is inserted in the neoblue blanket light box. natus’ investigations have shown that
this failure occurs after extended exposure to the intense light source within the box, at which time the pad no
longer provides the therapeutic treatment for which it is intended. following the guidelines of this technical bulletin
will help to prevent failures from occurring on customer systems. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The purpose of this field corrective action is to provide a warning to clinicians who are treating jaundiced preterm infants, <35 weeks of gestation, with intensive phototherapy as defined by the 2004 aap clinical practice guideline as intensity >30 uw/cm/nm. this new warning is consistent with an expert panel recommendation published in 2012 in the journal of perinatology.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Natus is sending this safety notice to you as we are contacting all customers who purchased an
updated neoblue blanket system between march 2016 and august 2016 to ensure they have
an updated technical bulletin. the need for this action is described in the attached customer
letter and technical bulletin. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The neoblue blanket system you received included the reliability update to prevent the
potential early degradation and melting of the fiberoptic bundle at the pad connection to the
neoblue blanket light box. this reliability update was intended to prevent the previous
discoloration and melting, and natus wants to ensure that you do not experience any further
issues. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
This notification is related to a prior notification and technical bulletin that you received
around march 2015 regarding the neoblue blanket led phototherapy system. at that
time, natus informed you of a potential issue of discoloration/degradation/melting of the
fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box.
included with that letter was a technical bulletin which described the issue and addressed
many of your potential questions.
natus is in the process of confirming an updated neoblue blanket configuration which will
not be susceptible to the degradation described above. however, the date of project
completion is uncertain at this time. natus will contact you when the new configuration is
available, at which time we intend to initiate a field corrective action to replace or upgrade
your device(s). .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
With this field safety notice (fsn) we want to inform you
about a potential malfunction of nihon kohden bedside
monitors series life scope g9 (csm—1901) with main
units cu-191rk and cu-192rk and software versions
01-16 to 01-22.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Nova biomedical corporation has recently become aware of a software issue on the stat profile prime
analyzers listed above when using stat profile prime auto-cartridge quality control (a-qc) materials
(also referred to as “onboard quality control” or “internal quality control”).
stat profile prime analyzers that do not utilize auto-cartridge quality control materials are unaffected by
this software issue.
stat profile prime analyzers that only use traditional external quality control materials (glass ampules)
are unaffected by this software issue. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Alcon has observed that multiple shipments or forceful impact to a caster on a luxor/lx3
microscope may stress the microscope base, which could contribute to a caster breaking or
detaching from the base.
during in-facility transfer, should a caster break or detach from the base while the microscope
arm is not in the most inward locked position (as shown in figure 1), the unit may tip if the
microscope arm is extended (as shown in figure 2) over the location of the broken caster. this
may lead to the potential for physical injury from the microscope tipping or falling. two incidents
of physical injury have been reported in conjunction with this issue.
as a precaution, we are voluntarily inspecting and retrofitting luxor / lx3 units with new bases
and / or an updated caster configuration. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
FSCA ID: 2016.069
Causa
Alcon is initiating a medical device removal for specific lots of the acrysof® iq intraocular lens (iol) with ultraserttm delivery system. we are initiating this voluntary removal because we have determined the ultraserttm delivery systems from certain lots have an interior surface characteristic that could result in the iol becoming lodged in the ultraserttm delivery system. most likely if this happens the lens would not be delivered and the surgery could be completed with a standby lens; however, if the lens is forced through the nozzle this could result in damage to the lens and/or nozzle, possibly injuring the patient. please note that this event affects only a small portion of the ultraserttm delivery systems within the specified production lots. national competent authorities have been notified of this action. below please find the full details on this matter and directions for handling potentially-affected product in your practice. details on affected device: the acrysof® iq iol with ultraserttm delivery system is a ce marked medical device. the alcon acrysof® iq iol is an acrylic foldable single-piece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. the acrysof® iq iols are provided in the ultraserttm pre- loaded delivery system for a convenient, controlled means to reliably place these lenses into the capsular bag. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Novo nordisk has determined that | e2 | sca used in a small number of batches of novopen® echo® pens, cracking or breaking when exposed to certain chemicals, such as certain cleaning agents. novopen® echo® injectors are used to treat people with diabetes with insulin.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
A customer inadvertently used an expired occlutech flex ll
pusher cable and noticed doing so shortly after the
implantation procedure. there was no impact on the patient,
the procedure, or the product performance.
occlutech occluders and compatible pusher cables are
packaged together into an occlutech product set which also
contains the instructions for use and the patient information
card. the outer label on the occlutech product set clearly
shows the expiration dates of both the occluder and the
pusher cable. as these dates can differ from each other it is
important to check both dates to not miss the shortest
expiration date.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Olympus xx is writing to inform you that we are issuing validated, new reprocessing instructions
for the olympus tjf‐145 duodenoscope, consisting of revised manual cleaning and disinfection
procedures to increase the safety margin against infection after ercp using the tjf‐145.
these new reprocessing procedures should be implemented as soon as possible. the new
cleaning procedure requires the use of a new cleaning brush (maj‐1534), which is enclosed with
this letter.
after the enclosed brushes are consumed, the brushes will be available for purchase in sufficient
quantities to meet your facility’s needs through our normal sales order process. please note
the maj‐1534 brush is a reusable brush, which can be sterilized by autoclave following use.
instructions for sterilizing the maj‐1534 brush can be found in the enclosed, new reprocessing
manual. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Olympus has initiated the implementation of the [field safety corrective action (fsca) / removal measure] for the above monopolar high-frequency resection electrodes. the electrodes are used for endoscopic diagnostics and treatment in urology and gynecology.
olympus has taken this [safety corrective action / removal measure] because it has received a large number of complaints about loop breaks at the distal end of said electrodes. investigations have confirmed that the loops can actually break during the intended use of the electrodes. the loop particle can then fall into the patient and need to be removed. in certain cases, additional surgical treatment is required to remove this particle. in addition, this can prolong the procedure and, consequently, the duration of the anesthesia.