Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Physio-control has become aware of an issue where the etco2 reading can intermittently show a value of “xxx” after start-up or during device operation.
during the investigation, the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 12 or lifepak 15 will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated.
in this situation, the etco2 monitoring functionality will no longer be available.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
It has been identified that the 43-trl-inserter can wear causing it not to function as designed. this wear may cause the trial spacer to become detached from the inserter while in use. if this takes place then the trial spacer may be difficult to remove from the patient which may cause patient injury during this removal process.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Prince medical has recently conducted new biocompatibility tests on the nasobiliary drainage catheters. the results of the tests showed a cytotoxic potentiel of these products.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
A hoist spreader (carry) bar became detached during a patient transfer. the investigation identified that a bearing washer had been omitted during the assembly process of a carry bar.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Up to this date, pro med instruments became aware of two breakages of the pin tips, which occurred during two identical surgery procedures, both with the same physician. the breakage occurred at the very distal end of conical part of the skull pin tip. these two breakages did not cause any injury for the patient and/or any third party.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Radiometer has recently become aware that when the operator detaches the fixation ring from the paper liner, in some cases fractions of the paper liner’s surface coating sticks to the adhesive surface of the ring.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
A software upgrade for the abl80 co-ox analyzer is now available. this
software version includes minor software enhancements and bug fixes only.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Radiometer have released a new software version, v8.3.34, as well as a hardware module featuring an automated hematocrit determination and adjustment. please note that both the software and the hardware must be upgraded simultaneously. the new software cannot run without the hct hardware and the new hct hardware cannot run with previous software versions.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Radiometer recently became aware that some membranes may have enzyme residues on the outer membrane. upon replacement of the lactate membrane the enzyme residue may cause an initial negative bias on the reported lactate result.
the bias decreases over the in-use time, and depending on the amount of residue it may take anything between hours and days for the bias to disappear.
worst case the bias upon membrane replacement is -1.5 mmol/l at lactate levels over 7.0 mmol/l. this is most apparent when comparing results measured before and immediately after membrane replacement.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The linearity of the glucose is dependent on the oxygen tension of the sample. this dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase. very low po2 levels can influence the linearity of the glucose sensor. as a consequence of this glu results will no longer be reported when the po2 value is below 25 mmhg.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Radiometer has become aware that some d788 pco2 membranes can cause biased measurement results on patient results as well as qc results. the bias can be seen after the replacement of the membrane, and will be positive in the low range and negative in the high range. there is a risk of wrong diagnosis and maltreatment of patients for biased measurement results in the high range , root cause investigation is still in progress, but the preliminary root cause is variations in the thickness of a silicone layer used in the membrane units.
the error was discovered through internal testing on blood and qc material in connection with a capa raised to document the investigation of an issue regarding low qc comparison results.
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bfarm update action:
your local radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and abl800 series analyzers. the improved sealing ring may be identified by its blue color.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
(in january 27 , 2011 ) sensor cassette 946-008 lot r0031 has been found to exceed specifications for the parameters ph, k, na, ca and cl. the error resembles a positive bias on the reference electrode, increasing in size from installation of the cassette. the resulting parameter bias is of the order of 9 mmol for sodium, 0,1 mmol for calcium, 0,2 mmol for potassium, -0,018 for ph and -7 mmol for chloride.
two incidents regarding lot r0031 were reported from the field, one from belgium (radiometer ref. rbnl 576990103) and one from finland (radiometer ref. trio 579829752). no reports of death or serious injury were received, but the chemist at the finnish hospital suspects that patients could have been maltreated. the clinical risk assessment of the belgian incident states that the error could lead to clinical serious misinterpretation and mal-therapy in the critical care setting if it should happen again.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The expiration date for the abl90 flex sc is 4 months from the production date, including the 30 day in use lifetime . sc90 946-008r0124 (42 cassettes #88-129) were produced on 2012-10-23, while the labels were erroneously printed with the expiration date 2013-10-23. the chip in the sc is encoded with the date from the barcode label, and is therefore also incorrect.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The patient result mix-up occurs if:
• the communication line is interrupted or disconnected
• two or more patient results are queued for transmission
• the communication is re-established and the analyzer transmits the results in the queue.
in this situation the first result will be transmitted with the correct patient id, whereas succeeding results in the queue will be appended to the first patient id.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
If the connection between an abl and a hospital information system is broken, the results are queued for later transmission. if the abl and his are configured with the data transfer protocol hl7 version 2.5 any results in the queue will be mixed up when the instruments transmit the queue after reconnection. the root cause is the inherent software design.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The root cause for the carry-over has been identified to be a deficiency in some cup wash units. that is, the steel tube, which empties the cup during the cup wash process, is too long causing it to touch the bottom of the cup. in this situation an un-bound tracer-analyte complex can bind to the tube and carry-over into subsequent tests.
the countermeasure, which reduces the length of the steel tube by 0.4mm to ensure that there is a clearance between the tube and the bottom of the cup.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Radiometer have recently become aware that there is a potential risk of electrical shock for the operator.
the electrical shock may appear under the following conditions:
• the monitor is connected to the mains outlet and the mains switch is on
• the battery is fully charged (or no battery is present)
• the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor off
• the operator touches the two metal pins on the mains plug or on the monitor’s line cord receptacle after disconnecting the line cord.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The patient result mix-up occurs if:
• the communication line is interrupted or disconnected
• two or more patient results are queued for transmission
• the communication is re-established and the analyzer transmits the results in the queue.
in this situation the first result will be transmitted with the correct patient id, whereas succeeding results in the queue will be appended to the first patient id.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Radiometer recently became aware that wrinkles might arise on the outer membrane of these membrane units upon installation. retention of fluids between the wrinkles can cause a positive bias of approx. 14% when measuring on whole blood at a level of approx. 0.80 mmol/l.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
If a user scans the insert barcode for lot 65 or higher and the analyzer was not upgraded to software v1.44 then the scanned range for po2 will be incorrect. the analyzer will provide no warning that the range is incorrect. for this reason the upgrade to software v1.44 is mandatory.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
A buffer overflow may occur on the main board during a flush, which takes place when the aqt90 has been idle for more than 6 hours.
the overflow could cause the analyzer to enter into an error stage with different error messages and would require a restart of the analyzer to proceed. this stage is known as the “usb software error”.
in some situations the analyzer would lose current calibrations requiring a recalibration.
this means that the temporary workaround described in the technical bulletin – to restart the analyzer when it has been idle for more than six hours – is no longer necessary.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Release of anti-virus scan tool for field service engineers.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
If a user scans the insert barcode for lot 65 or higher and the analyzer was not upgraded to software v1.28 (or higher) then the scanned range for po2 will be incorrect. the analyzer will provide no warning that the range is incorrect.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Radiometer has recently become aware that one lot of membrane boxes has been produced using an incorrect electrolyte solution.
some of these membranes have been found to calibrate and provide valid results on the analyzer for a few days (4-6 days), before cal 2 fails on zero point. when this happens the membrane units will have a rapidly increasing positive bias until they are rejected by the following cal 2. cal 2 is run every 4 hours, and within this time slot there is a possible risk of obtaining wrong measuring results.