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 affected lots’ negative predictive value remains unchanged and is nearly 100%. it is only the positive
predictive value that is affected. thus, you may choose to continue to use the affected lots to report negative
results and perform alternative confirmatory testing on all positive specimens. however, there are risks
associated with this choice. the crag lfa is the most sensitive, commercially-available test for cryptococcal
antigen. the risk associated with confirming all positive specimens with a less sensitive test is that true, low
titer specimens may be negative using a less sensitive test method. thus, a true, low titer positive specimen
may be incorrectly reported as negative. clinical evidence must be used in conjunction with test results.
.
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
While training users with sterile packaged original parts, it was found that at 2m inlay 15 ° for the mutars® rs cup and lumic® tin ø 38/39 mm, one safety ring was incorrectly mounted in the inlay groove. it cannot be ruled out that this installation error may have occurred in other sizes.
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
Imtmedical has identified a potential risk associated with the user interface controller software of the
bellavista ventilator. please ensure that all potential users are made aware of this safety notification and
the recommended actions.
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 june 14, 2016 greatbatch medical identified an issue with the 00-7804-080-00 offset reamer
handle, as field complaints were reported that the drive chain mechanism seizes during use. the
function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an
acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non-
functional in the operating room.
the risks associated with this failure are:
1. the offset reamer handle seizes and the surgery must be completed with an alternate
device, leading to a delay of 30 minutes or greater from the scheduled surgery time.
2. the offset reamer handle seizes and no replacement device is available in the hospital,
leading to an interruption and rescheduling of surgery. .
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
Lntegra lifesciences corporation (lntegra) has identified that there is a possibility that some customers
received a camino® advanced monitor (camol), in which the optional sys/dias mode displays
reversed systolic and diastolic intracranial pressure (icp) values.
the camino® advanced monitor is a compact. portable device displaying intracranial pressure,
intracranial temperature (ict), and calculating cerebral perfusion pressure (cpp).
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
Choosing the wrong network or using an unsupported network can lead to incorrect biopsy results or failure to address the objective of the investigation.
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 issue happens for rf projection images. if user measures on rf image, "cal" (calibration) is not displayed and measurement is not correct.
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
There is a possibility the valve of the bvm manual
resuscitation system may become stuck during storage. this could result in the
intended tidal volume not being delivered through the valve, which may cause a delay in
treatment.
the instructions for use provided with these products include the requirement to ensure
the bag, valve and oxygen delivery is functioning correctly prior to use. this field safety
notice gives additional information relating to this specific problem and the additional
actions required. .
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 manufacturing fault has been identified with the intersurgical bvm manual resuscitation
system, which could result in the directional valves positioned on the ‘back plate’ of the self-
inflating bag being orientated incorrectly. the images show the incorrect and correct
orientation of the directional valves.
the incorrect orientation of the directional valves could result in the bvm manual system
becoming over pressurised, which could result in patient barotrauma.
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
You do not need to return any covers that may have problems with tear-off labels, as stated in past notices. containers that may have problems with tear-off labels can continue to be used if the covers are inspected according to the instructions given in past messages. .
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 primary packaging of these products may show leaks in individual cases. as a
consequence, liquid may escape. direct contact with certain substances contained in this
liquid may lead to skin irritation. .
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
Molnlycke identified a potential safety hazard. during the handling of product complaints, micro perforations on some barrier sets were detected when immersed in the product testing.
although the kits are manufactured in the same environment and subsequently sterilized, the sterility of packaged products cannot be guaranteed in this case. molnlycke has taken the risk in this case seriously and is now recalling all the products listed in the attached list.
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
Mölnlycke health care barrier® easywarm® product contains warmers to provide heat. according to a stability study the warmers have passed its intended performance for all time points except for 3,5 years, were the product did nog give sufficient amount of heat. based on this mölnlycke health care gives an advisory notice that products that are 2 years old or older should be scrapped and will be replaced free of charge by mölnlycke health care.
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
Permobil ab has voluntarily initiated remedial action for certain models of permobil motorized wheelchairs with fixed seats and lifting inner tubes. the decision for this remedial action was made because of a possible failure of the upper panel, where the seat system is separated from the base. the top panel is the component that connects the wheelchair seat system to the base with several welds.
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 have within the framework of our ongoing quality checks unfortunately ascertained that in
the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our
monitor mounts and support arms, the riveting of the rotation may possibly not have been
carried out according to the specifications. in exceptional cases, it can lead to a loosening
thereof, respectively to a loosening of the connection plate in the case of continuous use,
which can in turn lead to a risk to patients, users or third parties. for this reason we have
decided to carry out a replacement action.
on account of the fact that no case of damage has hitherto occurred in practice, this relates
to preventive measure with regard to our deliveries, for the limited time period from may to
november 2015.
based on our records, we have discerned that you have been supplied by us, with the
affected products, during the aforementioned time period. a detailed list of relevant orders
can be found in an annex to this letter.
.
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
Immucor is issuing this product notification regarding the v antigen typing for donor e1011, cell #11 of
panocell-20, lot 52872. additional dna testing of donor e1011 has confirmed the donor as v–, instead of
v+ as indicated on the master list.
.
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
Immucor is issuing this product notification regarding the v antigen typing for donor d1741, cell #4 on
capture-r ready-id, lots id324 and id325. further dna testing of donor d1741 has confirmed the
donor as v–, instead of v+ as indicated on the master list. .
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 have determined that the lifecodes quik-ld class ii lot indicated above may generate invalid assays
due to high negative serum control (nc) values. per the lifecodes quik-id class ii instructions for use
(ifu), the average negative control value must be <_0.225 od. an increase of the nc average od above
this limit would result in a failed assay. where the nc is increased without achieving values above this
limit, samples may demonstrate false negative results (borderline reactivity) at or near the cutoff for the
assay.
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 reports are of inconsistent staining of cells and false positives reactivity with negative
control samples. the reports indicate the stain is not sufficiently removed from the adult cells
during the elution step; therefore it is difficult to distinguish fetal cells from the adult cells. a false
positive reaction with the negative control invalidates the test results and a repeat of the test is
needed. such repeat of testing may lead to delay in analysis of patient results and ultimately
delay in patient treatment. .
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 reports that immucor has received concerning unexpected positive
reactivity when testing donor n3512 with anti-v. our initial investigation into these reports has confirmed
that donor n3512 is v+ when tested with additional sources of anti-v. donor n3512 will be labeled as v+
going forward.
.
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
As a result of a complaint investigation, we have concluded the hla-drb1 sso typing kit, the
hla-drb1 eres sso typing kit and the hla-dqa1 /b1 sso typing kit have a minor impact
due to an error in the match it! dna 3.27.0 allele database update. the iot specific software
files for the hla-drb1 sso typing kit (628923), the hla-drb1 eres sso typing kit
(628925) and the hla-dqa1/b1 sso typing kit (628930/628930r) have incorrect probe
assignments for some alleles which could iead to a potential mistype of certain alleles.
.
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 would like to inform you that ivoclar vivadent ag is removing helioseal clear from circulation as
a precautionary measure.
it cannot be warranted that the material of the affected lot can be sufficiently cured with all
polymerization lights.
.
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 product has been interchanged with another dental alloy with comparable chemical composition. the product you've received is mislabeled.
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 affected polisher may suffer increased wear during use. in this case there is no
increased health risk to patients, users or the environment.
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
Jarvik heart, inc. has been requested by the french competent authority, ansm, to issue a field
safety corrective action (fsca) based on two (2) incidents involving disconnection of the
pedestal cable (jhi-201) resulting from the use of oily or fatty substances near the pedestal
connector. both of these disconnections occurred in a hospital environment, activated an alarm.
and were promptly addressed by a clinician re-connecting the cable with no harm to the patient.
the cable was later replaced.
jarvik heart, inc. is aware of only two (2) reportable incidents of this type in over five hundred
(500) implants of the post-auricular cable, jhi-001. based on the reported events, the
occurrence rate for this type of incident is 0.4%.
.