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.
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Siemens healthcare diagnostics has determined that dimension vista® ammonia (amm) lots
16187be, 16225bb, and 16265ab do not meet the 60-day calibration interval claim due to
reagent instability and results may show an abnormal assay [e143] message. these lots may
exhibit accuracy shifts for quality control and/or patient results (table 2) which may cause
laboratories to recalibrate more frequently than the 60-day claim in the instructions for use
(ifu).
siemens and the reagent supplier are conducting additional testing to monitor stability for newer
reagent lots to ensure no other lots are impacted. .
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.
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Siemens healthcare diagnostics has identified the following five feature issues with the syngo®
lab data manager (ldm). it is extremely unlikely your laboratory would experience any of the
issues described below. if an issue were to exist the user would be made aware via system
alerts, quality control processing status or standard syngo ldm rule validation. however,
please review this letter in its entirety and ensure that all operators understand the information
presented.
.
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.
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Siemens healthcare diagnostics has determined that dimension vista® blood urea nitrogen
(bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba, 15320bb, and 15341ac may
exhibit inaccurate patient and/or quality control results. the issue has been isolated to flex®
reagent cartridges manufactured from specific mold cavities. our investigation indicates loss of
activity of the gldh reagent wells from specific mold/cavity identifiers as described in table 2.
not all flexes are affected.
.
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
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Siemens healthcare diagnostics has determined that dimension vista® blood urea nitrogen
(bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba, 15320bb, and 15341ac may
exhibit inaccurate patient and/or quality control results. the issue has been isolated to flex®
reagent cartridges manufactured from specific mold cavities. our investigation indicates loss of
activity of the gldh reagent wells from specific mold/cavity identifiers as described in table 2.
not all flexes are affected.
.
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
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Siemens healthcare diagnostics has confirmed that the concentrations for biotin listed in the
non-interfering substances section of the current dimension and dimension vista instructions
for use for dimension tni, dimension vista digxn, e2, ferr, prl, tsh have incorrect units,
and incorrectly state the level at which biotin does not interfere. in the cases of tni, e2, ferr,
prl, and tsh, there is significant interference at the levels incorrectly stated in the current ifu.
dv e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays)
exhibit a negative bias. digxn si units for biotin are incorrect by a factor of 100 lower than the
level at which biotin does not interfere, in the current ifu.Dimension (dm) and dimension vista
(dv) affected 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.
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Siemens healthcare diagnostics has confirmed that the advia centaur systems myoglobin
assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the
advia centaur myoglobin instructions for use (ifu), for all in-date reagent lots when evaluated
with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed. .
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
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Siemens healthcare diagnostics has confirmed that dimension vista® chem 1 cal lots 5gm081
and 5gm082 may produce depressed results with current lots of calcium reagent. although the
affected chem 1 cal lots are expired, the calcium calibration interval is 90 days; therefore, it is
possible that calibrations using the calibrator lots in table 1 are active. .
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.
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Siemens healthcare diagnostics is conducting a recall for the immulite® 2000/immulite®
2000 xpi intact pth (intact parathyroid hormone) (ipth) assay kit lot 320. siemens has
confirmed that immulite® 2000/immulite® 2000xpi intact pth kit lot 320 listed in table 1
can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml with
serum and edta patient samples vs. a reference kit lot. .
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
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Siemens healthcare diagnostics has confirmed that dimension® creatinine (cre2) assay
exhibits a negative bias at the low end of the urine analytical measurement range (amr) (see
table 2.). the limit of quantitation (loq) claim (5 mg/dl [442 µmol/l]) for urine samples is
not met. siemens is actively investigating the root cause of the issue and is working to
implement a solution. this issue also affects all future lots of cre2 until a solution is
implemented. the serum/plasma cre2 amr is not affected by 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
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We have observed that in single cases the absorbance value obtained for the enzygnost® anti-hcv 4.0 control, positive on bep 2000 / bep 2000 advance system can be found lower than expected. the occurrence of this issue is triggered by an instrument liquid handling step (conjugate pipetting) in conjunction with enzygnost anti-hcv 4.0. as a precautionary measure we would like to inform you that an enhanced liquid parameter setting is now available for the enzygnost anti-hcv 4.0 method on bep 2000 / bep 2000 advance system. this enhanced setting has been verified internally and leads to a more robust assay performance. there is no change in the assay format, only a minor adjustment of the liquid parameter setting for the enzygnost anti-hcv 4.0 conjugate transfer step. .
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
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During internal investigation it has been observed that we provided a defective file to install the
innovance dti assay setting on the sysmex 08-5100 system to our field service staff. the
provided installation file for the innovance dti assay contains an incorrect analysispreset d.
this can cause an invalid calibration curve of the innovance dti 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
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Siemens healthcare diagnostics products has confirmed that the mentioned enzygnost anti-vzv/igg lots can show a higher variation in homogeneity. this can lead to invalid runs by not meeting the run validation criterion for the reference p/n at the start and end of a series.
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
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Siemens healthcare diagnostics has confirmed that under very rare circumstances a false
negative result may be reportable.
the issue may only occur under the following conditions:
• the initial result is falsely flagged with an antigen excess error that triggers an automatic
remeasurement in a 1/19 dilution.
and
• the raw signal of the remeasurement is below the limit of blank (lob) of the method.
under such conditions the low remeasurement raw value may be strongly affected by the signal
noise of the optical system and can generate an erroneous low optical raw value. this raw value
will be corrected by the dilution factor and can be deduced from calibration curve in a false low
range. .
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
Erroneously high factor ix results with applications on bcs/bcs xp system at the lower end of the measuring range.
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
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Siemens healthcare diagnostics has observed that in very rare cases false short clotting times
for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false high
pt % of the norm or false low pt inr values.
these false short clotting times were observed with turbid, hemolytic and/or icteric samples from
intensive care patients. the corresponding reaction curves of these rare samples showed a pre-
peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by
the existing check algorithms. an example is given in figure 1. (left: expected reaction curve;
right: erroneous evaluated reaction curve). .
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
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It has been reported that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 “no x-ray - fd reinitializes‘ may occur. the error refers to a potential hardware malfunction which requires a part replacement. when this error occurs, the system w i become inoperable i.E. no x-ray) until the affected part is replaced.
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
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We are writing to notify you to conduct a system check prior to performing examinations
using a sensis system.
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
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Our service organization will contact you to arrange a date for the installation of the software update. please feel free to contact our service organization for an earlier appointment. this letter will be distributed to affected customers as update axo48/15/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
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In the application “dsa roadmap” the artis system's intended behavior is to reject the
stored vesselmap from previously acquired dsa if the patient table was moved during the
roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses
it for the further roadmap workflow steps.
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
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Siemens healthcare became aware of possible incorrect tube current calculations by the care dose4d
algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical
shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate.
potentially, the care dose4d software will select the maximum tube current for the uppermost part of the
skull, thus leading to unnecessary radiation exposure.
.
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
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The artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap
ring is used to secure the bolt.
in case of a missing or wrongly installed snap ring the bolt could slides out of its base. and
the table top carriage will slide to the floor.
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
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For artis systems with software version vc21 c, vd11, and megalix cat+ x-ray tubes, the semi-automatic focus
switch may in cases of a special type of defect in foci "small" and "micro" (if present), does not work as intended
when pressing the footswitch multiple times. this special type of focus defect, that causes the failure of the semi-
automated focus switch, becomes more likely as the service life of the x-ray tube increases.
as a matter of clarification systems with software version vc21 bare not affected. .
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
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Axiom artis semiautomatic focal point switch with vb35e software version and megalix x-ray tubes may not work properly if the "little" and "micro" focal points are damaged when the footswitch is pressed repeatedly. this particular type of focus failure that prevents semi-automatic focus shifting is more likely with a longer x-ray tube life.
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.
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This letter is to inform you that we have reason to believe that in some cases the quench
lines for some superconducting magnets may have not been properly installed. therefore, it
is necessary to check whether the quench line for your mr system was installed in a manner
that ensures safe operation. siemens considers the safety of patients and users our highest
priority; therefore, we are notifying you of 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
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This corrective action addresses two possible, mutually independent causes of a system
defect.
o in artis zeego systems, angulations in the vicinity of the c-arm collision area can
cause the cable inlet to become clamped and can result in mechanical damage.
0 in artis systems with a100plus generators, an attempt to resume operation following
detection of a fault (such as a short circuit in the x-ray tube) can result in the failure
of a module in the high-voltage generator.
what is the imgact on system operation and what is the potential risk?
a fault can result in a spontaneous system malfunction that can only by rectified by our
service organization.