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 user selects the “convert to setup field” option when using the rt chart function in aria (versions 8.0 and 8.1), the dynamic multi leaf collimator (dmlc) plan components are removed in order to create an open collimator for field light setup. in the reported case (cp-03045 from the usa) a user selected this option in error and then converted the set-up field back to a treatment field. the dmlc was then missing from the resultant treatment field. if this error is not detected prior to patient treatment an open field treatment can result.
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
This letter is to advise you of an anomaly that has been identified with the imaging arms of the true beam accelerator where loose encoder pulleys could lead to inaccurate readout of arm geometry.
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 optical guidance platform (ogp) camera calibration is not designed or validated for durations longer than 24 hours. the ogp requires recalibration on a daily basis to ensure that the optical calibration is correct for proper patient alignment and monitoring before use in treatment.
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
An anomaly that has been identified with the clinac, trilogy,
novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size (refer to figure 1(attached). some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack.
if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an underdose of the intended target volume.
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
May deliver a photon beam with symmetry outside varian beam specifications.
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
Combining use of the 4d structure merge tool option with couch structure insertion in eclipse may result in the displacement of patient structures.
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 treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu or calculated dose distribution.
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
An anomaly has been identified within varian eclipse™ when used with aria™ radiation oncology (rt chart module) where adding a reference point in rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse.
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
Us endoscopy received a report of a grasping wire detachment during use.
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
Tubing becoming detached at the connect/disconnect location on the infusion sets.
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
This letter to inform you that manufacturer have identified that the suture breaking strength in few incidents are non compliant to european pharmacopeia requirements.
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
During continuous monitoring and analysis of trumpf medical products installed in the field, customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. investigation indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. the product has not been involved with any reported injuries, and there are no known safety risks related to it. as a reminder, the universal arm support is used to position and restrain a patient’s arm securely during surgery, as well as the induction and recovery phases.
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 universal arm support enables precise positioning of the patient’s arm during surgical procedures. during our continuous monitoring and analysis of trumpf medical products installed
in the field customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. the feedback describes the issue occurring while attempting to secure the position of the device. with this preventive field action trumpf medical proactively wants to ensure the safe intended use of the universal arm support. the product has not been involved with any reported injuries.
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
There a very small likelihood of the affected products moving on their own. as far as is currently known, this independent movement can occur without clearly identifiable external circumstances or conditions.
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
Bacterial contamination of con-zellin alcohol swabs lots starting with 7,8,9 & 0 included in individual test packs of optimal it (cat no: 710024) lot nos: od0013m, oe0017m & oj0025m.
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
In a limited number of the product oxygen sterile protection (pn: 60200), a protective green cover foil that protects the transparent part of the lens hood system is not removed after the assembling 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: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
During dicom export of plan level images with a non square exported field of view (fov), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose. when the anomaly occurs, the magnitude of the image shift can be a full iec-x voxel, a full iec-z voxel, or full voxels in both iec-x and iec-z.
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 radiopaque segment of the above catheters may detach during in vivo use, potentially resulting in device fragments remaining in the patient's vasculature.
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
Cartridges of this lot of oxoid antimicrobial susceptibility testing may contain individual discs that are not impregnated with antibiotic.
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
Whole blood samples (either fresh or frozen) for hba1c testing are pre-treated with multigent hemoglobin denaturant. the pre-treated samples are placed on the architect csystems and tested for glycated hemoglobin (hba1c) and total hemoglobin (thb) concentrations. according to the package insert, pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 °c prior to testing. pretreated
samples are stated to be stable for “up to 8 hours at 15 to 30 °c and up to 48 hours if stored at 2 to 8 °c”. however, recent studies have demonstrated that hba1c measurements increase with time after the samples are pre-treated. therefore, it is necessary to change the handling instructions for pre-treating
samples for the multigent hba1c assay. the investigation to determine root cause is ongoing.
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
An internal technical investigation has determined that thermo scientific™ remel™ shigella sonnei (phases 1&2) agglutinating serum (lots listed above) may fail to agglutinate within the specified minimum reaction time when tested with shigella sonnei phase 2 bacteria. continued use of these lots may result in a failure to correctly identify isolates as shigella sonnei phase 2.
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
An increase in the recovery of bio-rad quality control (qc)
containing lormetazepam when used with multigent benzodiazepines lot 13434m500.
polyclonal antibody based immunoassays that measure class compounds such as benzodiazepines will exhibit lot to lot variation with regards to sensitivity to various compounds within the class.
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 company identified through internal testing of sterrad® 100s sterilization process that several anspach attachments did not achieve the expected sterility assurance level (sal) of 10⁻⁶ .
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
As part of on-going discussions with the u.S. food and drug administration (fda) regarding cooler-heater cleaning guide adequacy, terumo cardiovascular systems (terumo cvs) has updated its cooler-heater instructions for use (cleaning guides).
despite the lack of confirmed complaints for infection associated with the use of any terumo cvs cooler-heater device, terumo cvs is issuing updates to its cleaning guides for specific products in order to provide customers with the most up-to-date information possible.
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
Specific subset of the h/sat probe assembly population is being withdrawn due to a supplied component in the optics, the optical module. a change by the supplier to a different material and anodization resulted in increased failures. h/sat probe assemblies are used in production and in service. the cdi system 500 monitor conducts an automated self-test when the device is powered on. if the monitor contains an affected component, a color chip test failure will occur and the h/sat probe will be disabled.