Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Spacelabs healthcare has received multiple reports regarding the following: - a failure to boot following power on or reset, resulting in monitor operation.- loss of network connectivity, which may result in;- an inability to display alarms and data from the affected monitor on central stations and other bedside monitors, or- a failure to transmit parameter and alarms from the affected monitor to system printers and sapcelabs’ intesys clinical suite retrospective database (including the clinical events interface remote notification feature).- display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor.- touchscreen failure where touching the screen does not produce the expected response.This issue is caused by inadequate electrical contact on one of the printed circuit board assemblies.
Acción
A small number of printed circuit boards with the affected socket were also distributed to customers to facilitate repair of customer monitors. Medtel Pty Ltd will contact affected customers to schedule a convenient time to replace the PCBAs in in their facility. Meanwhile customers are advised the following:
- The reported issues occur mostly at initial power on of a monitor. Always check for proper operation (such as functionality of touchscreen, proper language, and network connectivity) when the monitor is first turned on.
- If the product is monitored via a central station, ensure the notification feature for monitoring communication loss is on. The capability is on by default.
- If a bedside monitor is not monitored via central station, check the bedside monitor frequently to ensure the display is functional.
- Do not rely solely on the monitor for critically ill patients. This action has been closed-out on 05/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Philips has received customer feedback where the monitor ceiling suspension (mcs) system fell to its lowest position. in this specific occasion it collided with the table top. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs. when the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room or with other equipment in close proximity of the mcs.
Acción
Philips will replace all MCS actuators on affected devices. Until this action can be undertaken straps being fitted around the MCS to prevent the monitors from falling down in the event that the actuator fails.
In order to avoid any risk for patients, users or bystanders are recommended the following until the containment action has been implemented:
- Do not position or move the Monitor Ceiling Suspension above the patient.
- Do not allow staff to stand under or close to the Monitor Ceiling Suspension.
Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 03/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Following a regulatory review of the tissue morcellation system in general, the manufacturer has updated the contraindication guidelines section of the instructions for use (ifu) for this system.
Acción
Endocorp Pty Ltd is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators.
The TGA has published information on the risks associated with power morcellators on the TGA website at:
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 02/06/2016.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has determined through an internal investigation that some assays do not align with the representative data published in the instructions for use (ifu) for on-board stability, calibration frequency, and/or interference.
Acción
Siemens is requesting their customers to verify that the current IFU version for methods in use in the laboratory is being followed. Navigate to the Siemens Document Library for the current version of the IFU: https://www.healthcare.siemens.com/doclib. For on-board stability and calibration frequency changes, ensure that the ADVIA Chemistry system is programmed to reflect the changes indicated in the IFU. This action has been closed-out on 03/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Based on a concern raised in the us relating to the potential risk of transcoelomic spread of undiagnosed cancerous tissue with the use of morcellators in the treatment of uterine fibroids, the manufacturer has issued an updated ifu which has been included in this communication.
Acción
Olympus is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators.
The TGA has published information on the risks associated with power morcellators on the TGA website at:
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 18/07/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Baxter healthcare identified that the affected products (self-righting luer slip and luer lock tip caps ) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. the heat shrink tape used on the discpac package is the only product component that contains latex. the instructions for use (ifu) correctly identifies the content of latex. unintended or accidental exposure to latex has the potential to elicit a hypersensitivity reaction, especially in sensitised individuals. symptoms may range from skin irritation to anaphylaxis. baxter has not received any reports of adverse events associated with this issue.
Acción
Baxter is alerting its customers of this labelling issue of missing latex symbol in an effort to prevent unintended exposure to latex. Baxter is updating the labelling of the affected products to include the latex symbol for future batches. This action has been closed-out on 02/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Device technologies australia is informing the customers: intuitive surgical has found that the harmonic ace ifu used with the da vinci standard, s, and si surgical systems, contains incorrect instructions in regard to the proper use of the ininstrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counterclockwise. the correct instruction is to turn the irk clockwise.
Acción
Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Internal investigation results by roche diagnostics confirmed that certain lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with two lots of the elecsys cmv igm assay. roche confirmed that a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one of the three specific antigens included in the cmv igm assay. the signal reduction has only minor effects on the calibrators and controls (precicontrol cmv igm) and therefore is likely to remain undetected, resulting in false non-reactive cmv igm results and undetected acute cmv infections. in summary, there is a reasonable probability that the use of affected diluent lots may lead to delayed or incorrect diagnosis and/or treatment of acute cmv infection.
Acción
Roche Diagnostics is requesting the customers to discard all current stocks of affected Diluent Universal and replace with the Diluent Universal (11732277122 - LOT 181121) that has been shipped to the laboratories free of charge.
Roche Diagnostics is further requesting laboratories to review the Negative Elecsys CMV IgM patient samples tested between 1st November 2014 and receipt of this notice, whose results fell within the COI range of 0.5-0.7 COI and were obtained using one of the Diluent Universal lots and recommending appropriate patient re-testing with the new diluent lot provided. This action has been closed-out on 17/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of a potential safety issue involving the breakage of the steel cable which support the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there were no injuries reported as a result of this issue.
Acción
GE Healthcare will inspect, and repair as necessary, all affected systems. A GE Healthcare service representative will contact customers to arrange for this correction. Additionally, the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years, and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt. This is to ensure the ongoing safe operation of this device. This action has been closed-out on 16/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Maquet cardiopulmonary has received several complaints from the field reporting that after startup with either ac or dc power, the cardiohelp system generated the pop-up window "battery x needs service" or "both batteries need service" (x refers to the number of built-in battery, e.G.Battery 1). the alarm messages did not occur during device operation (including the switch from ac to dc power and vice versa) .Maquet cardiopulmonary's internal investigations have identified that there is a likely occurrence of the above mentioned error messages due to software bugs in the communication between the controller module and operating system . however, it is not possible for the user to distinguish the genuine alarm messages caused by batteries from the incorrect alarm messages caused by the software bugs. maquet cardiopulmonary received no reports of any adverse patient outcomes as a result of this error message.
Acción
The new software version (version 3.4.6.0) corrects software bugs that resulted in the generation of incorrect "Battery Needs Service" error messages. This software revision and the method for upgrading affected systems will be provided via the normal Service Letter process. This action has been closed-out on 11/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Edwards lifesciences (previous legal manufacturer of aquarius devices in the market) initiated a fsca to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. field safety notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.Nikkiso europe (manufacturer of aquarius devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing total fluid loss (tfl) management in software 6.02. this product improvement is accompanied by a revised instructions for use (ifu).
Acción
Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Grc surgical pty ltd, following recent advice and review of the instructions for use (ifu) of this device by the therapeutic goods administration (tga), is issuing a product correction to replace the ifu previously supplied with his product. the previous ifu has been identified as not containing sufficient warnings to adequately ensure safe use of the device. changes to update the ifu have been reviewed by the tga, and are in response to a tga safety advisory statement following advice by the urogynaecological devices working group on 4th august 2014 regarding the use of laparoscopic power morcellators (https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014) .
Acción
GRC Surgical Pty Ltd is requesting all the users to quarantine the devices until the existing IFU's are removed from circulation and replaced with the updated IFU. This action has been closed-out on 20/04/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required. no injuries attributed to the problem are reported.
Acción
Philips Healthcare is advising the user to always observe realtime dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. Philips Healthcare service engineers will install software release R7.2.8 which addresses the buzzer issue. This action has been closed-out on 3/8/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
In december 2014 radiometer pacific advised their customers of a potential significant clinical issue with patient results processed on the abl90flex analyser if the inlet is left open for more than 30 seconds after aspiration of the patient sample (rc-2014-rn-01365-1). although the analyser provides warning sounds and messages the problem can occur after the following sequence of actions:1. the operator aspirates patient sample a and forgets to close the inlet 2. the inlet is left open for more than 30 seconds before it is closed3. an operator aspirates patient sample bin this case the results for patient sample b are affected by this issue.Radiometer pacific advised a short term corrective action by providing a warning label for attachment to the analyser. this label provided instructions for action if the inlet has been left open.
Acción
A Radiometer Pacific representative will perform a software upgrade to version 3.1 MR3 on your ABL90Flex analyser to correct the issue and to remove the warning label issued as part of the original recall action. The recall for product correction letter will be provided to customers when the correction is carried out onsite. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Australasian medical& scientific ltd (amsl) is informing their customers that the safety and performance of these devices have not been properly evaluated and so the ce marking of the device is not valid.
Acción
Australasian Medical & Scientific Limited (AMSL) is requesting the customers to inspect their stock for the affected devices and quarantine all units. AMSL will arrange for the affected stock to be recovered and a credit note issued. This action has been closed-out on 03/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. it can be brought up to working condition again by simply pulling it out. the control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user. for siesta i breasy, siesta i whispa and mri 508 freshgas regulation and ventilator mode change (manual or ventilator) can still be done as this is mechanical and/or soft key controlled and doesn’t need confirmation by the control dial.For siesta i ts and intellisave ax700 it is not possible to regulate freshgas delivery or change ventilator mode as this needs confirmation by the control dial.For all machine types ventilation will continue at the previously set parameters.
Acción
Device Technologies is requesting all its customers to check their machines for the faulty control dial and is replacing control dials on devices exhibiting the issue. End users are provided work around instructions to assist in the continued use of affected units. The anesthesia machine can continue to be used as the control dial can be pulled out, making the control dial work. This action has been closed-out on 08/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Vitek 2 software ver. 7.01 introduced a feature (enable > convention for highest reportable mic) which can be used to modify the ast (antimicrobial susceptibility testing) reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation.The enable > convention for highest reportable minimum inhibitory concentration (mic) configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a > (greater than) symbol. for example, =32 (highest reportable mic) would be modified to >16 which are equivalent for mic testing.Patient isolates function as intended; however, the software does not recognise the two values (e.G. =32 vs. >16) as equivalent, and incorrectly flags the modified value as a deviation.
Acción
Biomeriux is requesting their customers that in the event of a QC deviation for one or more of the ATCC strains and antibiotics indicated, to compare the reported MIC value to the expected MIC value. If the values are equivalent, the deviation is subject to the software discrepancy and can be ignored. This issue will be corrected in software release 8.01 This action has been closed-out on 09/08/2016.