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
Varian has identified an installation anomaly whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification. in the worst possible scenario this could result in the counterweight detaching from the gantry; and the resulting unbalanced gantry may swing freely, posing a hazard of a collision with a patient, therapist, or service person.
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
Philips has recently become aware of collisions and excessive force exerted on the lower portion of the detector arms of precedence and skylight spect systems which may have resulted in the detector arms breaking. a collision or excessive force may lead to a crack or fracture in the upper portion of the arm, which may cause the detector arms to break and the arm and detector to fall.
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
Potential underestimation of temperature values during monitoring.
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, MHRA
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
This advisory notice is to provide you with updated information on multi-isocenter plan management and acquisition of couch parameters for multi-isocenter plans at the 4ditc.
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
Potential defect in the packaging of select lots of these products produced during the september 2010 to december 2010 timeframe. this packaging defect could compromise the integrity of the primary seal on product packaging for the identified product codes/lots.
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
Edwards lifesciences is announcing a field safety notice (fsn) on all loader assemblies contained within the ascendra 2 delivery systems (the ascendra 2 delivery system consists of a balloon catheter and a loader, model number 9320as23 or 9320as26). edwards has received reports where, during the transapical procedure, the loader assembly de-airing mechanism has become partially unseated thereby creating an insufficient seal around the pusher and resulting in the leakage of blood.
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
1. when using the center on cursor feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr will move to a position where the 3d cursor is centered
on the screen.
2. when using the isocenter move mode feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr is correctly recalculated and shown.
3. when the image series is changed (on the top left corner of a drr view) while using drr blending, the captured drr is not recalculated or cancelled.
4. when using the blended drr function the visualization of the captured drr may change without the visualization parameters (mixing and depth control) being updated on-screen after choosing a drr preset for the active drr.
5. when a new beam is created after using drr blending on a previous beam, switching back to the previous beam may cause annotations for blending, mixing and depth control to not be shown.
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
The patient / priming detector is integrated in the venous clamp. if the start up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultras and ak 200 ultra machines for a patient treatment, a significant safety feature may be compromised, in which case the device may not be able to detect blood.
this issue may arise if the operator:
-fails to properly attach the venous line in the venous clamp during the priming procedure; and
-fails to verify the illumination of the machine blood path indication after patient connection; and
-fails to confirm start of treatment; and
- ignores the audible alarm and attention related to the achieved extra priming 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: 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
There is a potential risk of bowel perforation during trans anal irrigation or any other device for rectal insertion in general, whether using products with or without a flange which limits insertion depth. the company do not consider that the addition of a flange would eliminate the risk. a change to the design of the product has not been pursued and risk control measures concentrate on training and the precautions and contraindications contained in the instructions for 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: 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
Safety issue #1
the “view position” and laterality (e.G. lcc, rcc, lmlo, rmlo) is not displayed on mammography images on the web dx viewer. mammography images are expected to display view position and image laterality to support interpretation and diagnosis. the standard clinical practice is to verify laterality prior to mammographic‐based interventions or decisions. if the clinician does not verify correct laterality by an alternate means (e.G. by reviewing a correct hard copy, or by viewing the image on a mammography diagnostic workstation where the ‘view position’ and laterality are correctly displayed), then they could plan or perform an intervention or make diagnostic or treatment planning decisions on the wrong anatomic side or site.
safety issue #2
image orientation or annotations are not displayed properly for an image on webdx viewer when displaying a ‘key image note’ that refers to multiple images with multiple presentation states.
if a referring clinician relied exclusively on the ‘key image note’ for intervention or treatment decisions, and the annotations were essential for identifying or recognising the key finding, this
could contribute to an incorrect or sub‐optimal intervention or treatment planning decision.
details: the ‘key image note’ feature allows a radiologist to cue a referring clinician to critical findings/information based on selected key images. the ‘key image note’ can refer to multiple
presentation states when it references more than one image in cases. examples of different presentation states that might be included in a ‘key image note’ include, but are not limited to:
1) images are not oriented in the same manner;
2) images do not have matching modality lut information’
3) images do not have matching shutter information or graphic layer information.
under these conditions, when a user opens the ‘key image note’ on a webdx viewer, the presentation state is not fully preserved. consequently, some image annotations are not
displayed.
safety issue #3
when a user is viewing a ’current’ exam and opens a ‘prior’ exam concurrently, the presentation display settings are not applied to the ‘prior’ exam. examples of presentation display settings include, but are not limited to, orientation markers, annotations and window levelling. this may result in image orientation, window level, invert, and annotations not being displayed as intended when an exam is displayed as a ‘prior’. this happens regardless of whether the exam is displayed
as a ‘prior’ manually or via a hanging protocol. if a historical exam is opened independently (i.E.
not while a ‘current’ exam is open), all presentation state and related annotation information is
retained and correctly applied to the historic exam.
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
May be responsible to stop the normal fluid flow and then makes the product non useable.
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
(january 17 , 2011 )the implant(s) may contain a manufacturing defect. this condition may be present in a small percentage of the lot 910695 and it relates to a shallow depth of the internal hex. the condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. a complaint was received from a customer and the investigation showed that an incorrect machine tool was used during the manufacturing of the product and that related inspection protocols weren’t adequately followed.
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
Philips recently received a complaint that the patient table collapsed in the vertical direction with a patient on the table. philips has determined that the root cause was a failure with the vertical brake hub of the patient support.
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
A user stated there was difficulty passing an obturator through the cannula of the tracheostomy tube; this report was specific to the shiley 6.0 pdl, however is similar to the issue highlighted in
mda/2009/031concerning the shiley 3.O ped. the risk associated with this failure is the delay in ventilating patients.
december 16 , 2010.
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
Kinking of the tubing on the level one normothermic iv administration set. the kinking occurs on the small tubing coming out of the heat exchanger. this kinking is sometimes detected by the user when he opens the package, but sometimes, the kinking appears during the use of the level one.
this kinking results in an important reduction of the flow, without any alarm. therefore, if the kinking is not seen quickly by the user, it can lead to an important under-infusion.
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 fixing strap of these laser aiming devices may inadvertently be detached and land on a patient.
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 system was discovered where vmat (volumetric modulated arc therapy) plans were delivered as dynamic arc. it was determined that an older configuration of the clinac and older version and configuration of the linac vi software which did not recognize vmat plans was inadvertently installed.
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 internal testing in the factory it was found that the middle pedal of the footswitch (452270000141) does not always become inactive when the pedal is released. this is possible because not for all footswitches the required adjustments were implemented.
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 leak if handle is rotated past stop, potentially leading to underinfusion or interruption of therapy.
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
Potential to generate falsely elevated results when using the architect ivancomycin reagent,.
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: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
A fault in the lock plate of the cart, some lock plate are not thick enough to support the monitor under condition of frequent tilting. in a worst-case situation, the monitor can fall over.
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
Ge healthcare has become aware of a potential set of circumstances that could cause x-ray continuation during
an unexpected table stop on certain brightspeed systems. if this event were to occur on your system, patient
safety may be impacted.
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 device use modes can result in the etco2 and ventilation rate values displaying interchangeably under either the ventilation rate label or the etco2 label, potentially resulting in inappropriate 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
Bd has received reports of a blockage condition in association with certain batches of the microlance™ 30g x ½” needle. a small number of needles within the batches listed may be occluded or partially occluded. the condition affects the sterile and non sterile variants of the device.