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
Getinge has received complaints indicating that the central handle holder detaches easily from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. in this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
Acción
Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings.
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 become aware of an issue with the carescape central station (cscs) software version 2.0.2 units. after boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks. if a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the cscs and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation. there have been no injuries reported as a result of this issue.
Acción
GE Healthcare is advising customers who are experiencing the NO COMM safety issue to follow instructions outlined on the customer letter to restore communication between the CSCS and patient monitoring devices in the interim. GE will arrange for a software correction to resolve this issue.
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 identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.
Acción
Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange.
Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system.
It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera.
It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU.
Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.
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
As a result of customer complaints and subsequent internal investigations, beckman coulter has determined that an internal electronic component on the circuit “amplifier” boards system may be affected by a manufacturing defect. each fc 500 system contains seven (7) of the potentially affected amplifier boards. all instruments are potentially impacted. there may be impact to patient results due to this issue when using the fc 500 for any application, which may result in failures causing signal loss and/or signal drifting. the failure could present itself as signal loss and/or signal drifting resulting in absence of data or a shift in the population in the data plots.Customers have reported sudden loss of signal, intermittent signal loss, sudden upward or downward shift in signal, upward or downward drift in signal over time, fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation (cv) of flow-check beads.
Acción
All Applications including Laboratory Developed Tests, please review all data prior to the release of reported results from the lab and immediately implement the collection of Time as a parameter and create Time versus Parameter plots which will allow the monitoring of signal integrity during data acquisition
For tetraCXP and stemCXP it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. Users can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labelling.
For ClearLLab Reagents, CytoDiff Application and Laboratory Developed Tests, in addition to the actions above ensure that the appearance of the data patterns are reviewed and look for suboptimal compensation and ensure that the pattern appearance matches the statistical data reported.
For CytoDiff Application, in addition to the actions above, compare the results obtained from the cytometer to the results from the hematology analyzer for the same sample, and verify that there is concordance with the results.
Contact Beckman Coulter Customer Technical Support Centre or the local Beckman Coulter Representative if any of the issues described occur.
Consult with the Medical Director to determine if a retrospective review of results is warranted.
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
During internal testing, medtronic identified the potential for a sterile barrier breach in the pouch of all lot numbers of the above listed products. other packaging configurations, such as integrated affinity nt hollow fiber oxygenator/cardiotomy venous reservoirs and perfusion tubing packs with affinity nt cardiotomy venous reservoirs are not affected by this issue. no other medtronic products are affected by this issue.
Acción
Medtronic is advising users to quarantine all unused, non-expired, affected product for return to Medtronic.
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
A review of relevant data and feedback from users has identified there are some pump clogging and displacement of the colour coded label. the pump clogging could contribute to erroneous results for any assay performed on the vidas and mini vidas system due to decrease of pipetted volume.
Acción
bioMérieux is advising users to implement the following permanent changes in managing the affected systems:
1. Increase the frequency of the QCV testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed. In the event of QCV test fail, it is recommended to review previous results with the laboratory medical director, and perform a retrospective analysis of all patient specimens processed since the last successful QCV test. bioMérieux will update the User Manual to reflect this requirement
2. As indicated within the Instructions For Use, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place
In response, bioMérieux is taking action to help ensure the instruments perform as intended:
1. Pumps have to be changed every 7 years
2. bioMérieux will systematically clean the VIDAS/mini VIDAS pumps during the yearly Preventive Maintenance
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
Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
Acción
Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.
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 has been made aware of an issue with the artis one systems in conjunction with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a fixation ring is used to secure the bolt. in the event of a missing or wrongly installed fixation ring, the bolt will remain in place and the patient table may appear to operate normally. in extreme cases after long periods of use, the bolt persistently bears the unexpected force from non-vertical direction and may slide out of its base and lead to the table top carriage slide to the floor. no complaints have been received for the artis one system to date.
Acción
Siemens will be in contact with affected users to arrange for a service technician to examine potentially affected tables. The positioning of the bolt as well as the fixation rings will be verified and if necessary corrected or replaced.
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
Interpath have become aware of an issue regarding inconsistent volumes of citrate present in certain batches of the vacuette minicollect complete 1ml sodium citrate 3.2% tubes which may affect patient results.
Acción
Interpath is advising customers to inspect stock and quarantine all tubes of batch A171144P. Customers should then complete the reply form provided with the Customer Letter so Interpath may arrange for stock to be recovered and replacement stock issued.
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
Sybron endo received a recent increase in complaints relating to overheating buchanan heat pluggers only while used with the elements obturation unit (eou). when used in the eou, the affected buchanan heat pluggers exceed sybron endo internal specification and operating temperature specifications provided in the instructions for use (ifu). the heat pluggers tips are intended to heat to 200°c ± 50°c while in down-pack and hot pulp mode, 100°c ± 25°c while in back fill mode and 600°c ± 100°c while in cautery mode. internal testing demonstrated that some tips may exceed 700 °c upon activation, while in any operating mode (down pack, back fill, hot pulp test and cautery mode). when this occurs, the screen will indicate niti and the tip will glow red shortly after activation.
Acción
Kerr Australia is requesting users:
1. Inspect your device immediately and quarantine affected stock as outlined in the item numbers above to prevent further use; and
2. Examine current inventory for affected product and check the heat plugger to see if the NiTi icon appears and/or tip turns glowing red. (see instructions below); and
3. If you observe the NiTi icon and/or glowing red heat plugger tip, do not use heat plugger and return to Kerr. Please call customer care; and
4. Always follow the Instructions for Use when using the product
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
Convatec has been made aware of overseas complaints from users regarding swivelling of the suction tip of the handle of these devices. depending on the type of procedure, there is a potential for serious harm such as delayed recovery/delay in treatment, and tissue damage. it is very likely that the user may still be able to continue suctioning even after the suction tip starts to swivel within the handle. the chances of detecting the swivel by the user remain high.No complaints for this issue have been received to date in australia. no patient harm has been reported as a result of this issue.
Acción
Convatec is advising users to inspect the Frazier suction handle for a loose tip prior to use. Additional/alternative Frazier units may be kept on standby just in case users experience swivelling of the suction tip.
The manufacturer is currently validating a revised manufacturing process after shifting the bending fulcrum of the bending fixture from the handle to the metal tube thus reducing the impact of the bending force on the handle. After successful validation and product testing, the revised product will be introduced to the market.
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
Implant direct, through their regulatory affairs reporting process, have found that the extender that is packaged with the swishtapered implant have been packaged in the incorrect position (upside down in the plastic retainer). this discrepancy may lead to the possibility of the extender not seating properly in the implant.No reports of injury have been received to date.
Acción
Implant Direct is advising users to return any affected product.
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
Hologic has been made aware that the touch screen monitor provided with certain panther and panther fusion systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor. hologic has received 2 complaints where the glass panel separated from the panther monitor. to date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator.
Acción
Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.
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
Qiagen have identified an increased number of cases with altered ratios in the pyrogram peak patterns for therascreen pyrosequencing assays. use of the affected lots is associated with an elevated invalidity and re-testing rate.In addition, use of the affected lots also creates an elevated risk of a59t false positive results for the pyrosequencing analysis of nras codon 59 with the therascreen ras extension pyro kit (ref 971590).In pyrosequencing runs performed with the affected material, the ratio of the peak height for datp peaks in pyrograms is artificially increased while in parallel the peak height for dgtp may be decreased. this may result in an altered ratio of peak heights and consequently leads to an incorrect determination of allele mutation frequencies.
Acción
Qiagen is advising users to discontinue use of the affected lots and contact Qiagen for replacement lots.
Please ensure the corresponding assay Plug-in reports for automated result interpretation are used.
If users have used the affected lots, it is strongly recommend a review of the corresponding results.
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
Zimmer biomet has identified that specific serial numbers of dermatome an may have a loose control bar which could compromise the ability to control the thickness of the graft. the affected devices could also potentially have a loose width plate that if undetected, could result in an imperfect, yet still usable graft.
Acción
Zimmer Biomet is advising customers to immediately inspect stock and quarantine affected product. A Zimmer sales rep will contact sites to arrange return and replacement with an unaffected batch.
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 been made aware of a mounting issue with the 7th or 8th monitor to the monitor ceiling suspension. the 7th or 8th monitor attached to the monitor ceiling suspension may disengage from the suspension arm and fall down.Only allura xper systems with an attached 7th or 8th monitor on the monitor ceiling suspension are affected.When a 7th or 8th monitor disengages from the suspension arm it could pose a risk for the patient, user, bystander or service engineer.
Acción
Philips will be in contact with all potentially affected users and arrange for the set screws to be secured.
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
As a result of continuous surveillance on antimicrobial resistance, becton dickinson (bd) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (ast) results to colistin.The labelling currently provided with the bd gram negative panels (nmic) panels indicates that colistin susceptibility can be determined. emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the bd nmic panels with bd phoenix instrumentation.
Acción
BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product.
BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50; instrument customers where rules can be created in the software to identify resistant isolates.
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
Trumpf medical discovered that the radiated emission from the truvidia wireless receiver is above the normative accepted limits. it is unlikely, but possible, that the radiated emission may interact with other devices in the operating room, which may cause other devices to not function properly. the frequency of interference and associated risk will be dependent upon the immunity of the other devices for radiated emissions and nature of the failure mode of the operating room equipment being used at the time.
Acción
Trumpf Medical is advising users that an upgrade of the affected components will be completed as a permanent correction.
If users suspect that the device may be interacting with other devices in the operating room, switch off the wireless receiver (ensure the receiver is switched off, it is not sufficient to switch off the camera or control unit).
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
Beckman coulter has identified a potential issue, where belts on the x-axis (and on the y-axis, to a lesser extent) are showing premature failure and breaking.
Acción
Beckman Coulter will be in contact with affected users to arrange replacement of the affected belts by a service technician.
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
Signature orthopaedics has been made aware of an incident where an rci ha screw (7x20mm) box was opened only to find a reverse threaded screw in the box.
Acción
Signature Orthopaedics is advising users to quarantine affected stock for return. Replacement stock or a credit note will be issued.
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 march 2007 the minimum invasive grower (mig) component with locking mechanism was utilised with custom made long bone replacement implants for limb salvage procedures of skeletally immature or juvenile patients, to prevent unintended changes in the length of the device. the instructions for use (ifu) for these types of devices did not clarify the function of the locking mechanism and the warnings related to the locking screw until october 2014, resulting in potential lack of awareness of the locking mechanism and its function during that time.The omission of this information in the ifu has been identified as a potential risk in risk management files for custom made devices, with the potential effects including; prolonged surgery, instability, pain, impaired function (gait) and early revision. limb length discrepancy was also identified as a potential effect based on complaints data review.
Acción
Patients implanted with an affected lot number of the Custom Implants with MIG component should continue to be followed per the normal protocol established by his/her surgeon.
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
Beckman coulter has identified a potential issue with the tip present sensor within the robot of the aliquoter module. there has been one overseas report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. there is no impact to the sorter module associated with this issue.
Acción
Beckman Coulter will arrange field service engineers to inspect affected devices to inspect the tip present sensor for misalignment.
If users suspect or observe unusual contamination of the tip carrier arm whilst performing daily maintenance, as described in the IFU please contact the local Beckman Coulter representative immediately. If this is to occur, it is recommended to discontinue use of the Aliquotter module.
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 became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are:1- efov (extended field of view) check message does not display when fov is set >600mm for a paused scan2- prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "ct simulation"3- tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed4- tracker scan completed, no images were generated5- continuous link plans the clinical scan outside the surview6- applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan7- “system is still initializing. please wait…” error8- auto locations not functioning as expected9- system ended exam before completion10- system freeze-up after pause is pressed.
Acción
Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.