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 material used during the time of production of ksa orders of new beds showed sufficient firmness of the side rail and minimal required firmness of the weld. based on the reported cases in ksa we have revealed that the side rails and bed end may crack at critical spot of the weld during the standard 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
Varian medical systems has identified a problem in aria oncology information system (ois) for radiation oncology such that a user may inadvertently chart medical record information in an unintended patient’s chart.
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
Important software changes being made to your gentle pro laser system from the previous software (2.0, 2.1 and 2.2) to this rev 2.3a software release. major technical rev 2.3a changes:
• added an alternative preventative maintenance laser notification that is based on number of pulses and/or time
• improved security to access maintenance mode by authorized service representatives.
• improves the safety for the patient and the system by preventing specific faults not to happen.
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.
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 purpose of this letter is to advise you that your pump has an error that impacts the arabic language translation. if you do not use the arabic language setting on your pump, you may disregard this message. this translation error does not impact the functionality of the device.
devices do not need to be returned. additionally, we are not aware of this error occurring on any other medtronic insulin pump models.
this translation error occurs in the “predictive alerts” setting screen, which allows you to program alerts that will sound if you are predicted to reach your pre-set low or high sensor glucose values.
for your reference, below is a step-by-step guide on where you will find the arabic language translation error:
1. “main” > “sensor” > “edit settings”
2. select “predictive alerts”, then press “act”. the “predictive alerts high/low” screen may show that the alerts are turned off.
3. select “on”, then press “act”. the “set time sensitivity high/low” screen will appear.
kindly check the photo in the attached fsn
the “ منخفض / مرتفع “ header is incorrectly labelled in the arabic language setting and should instead read “مرتفع / منخفض ”. the value to program the low predictive alert setting is on the left, and the value to program the high predictive alert setting is on the right.
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 received a report in which the lithium ion battery in a philips pagewriter tc cardiograph overheated and ignited.
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
Two cases have been reported to draeger in which the incorrect connection of the breathing circuit resulted in the patients concerned not being connected to the anesthesia machine. the connections of the anesthesia machine and of the y-piece were short-circuited.
consequently, the patients did not receive the expected ventilation. in one of the two cases the patient in question suffered irreversible harm. in the other case the patient experienced a temporary and reversible deterioration in condition.
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: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169497
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this notification is to inform you that ortho clinical diagnostics determined that biased results may occur for specific vitros immunodiagnostic products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).
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
Boston scientific has determined through internal inspection, for affected products, the sterile barrier may contain seal defects.
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
Steris has identified that the software in the amsco 3052 and 5052 single-chamber washer/disinfectors equipped with an automated scs conveyor and barcode system may not process the cycle originally intended.
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
Yuyao yufeng medical equipment co., ltd is issuing a field safety notice to advise
users of an update to the instructions for use (ifu) for oxygen regulator yf-86-a
per the enclosed attachment (attachment 1). this information will be included in the
ifu & cartons of all future units distributed by yufeng medical.
this ifu update provides clear information about cleaning & disinfection method for
oxygen regulator yf-86-a.
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
Abbott has identified an issue with the alinity i gear pump assembly (part number a‐30108552‐01) resulting in foaming/bubbling out of the bottle reservoir for concentrated wash buffer and an unexpected amount of dried residue of buffer.
the foaming/bubbling is a result of an improper calibration of the pump’s operating speed.
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 workflows of your centricity universal viewer (uv) workstation can cause a loss of synchronization in the patient context between uv and either senoiris or idi mammo workstation.
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
Intuitive surgical identified that the sterile package for the insert can become damaged during transit. this damage can lead to a breach of the sterile barrier and potential for patient infection.
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 m220 optics carrier may unintentionally drop into the surgical field, risking contact with the 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
Medtronic records indicate that your facility purchased this product more than five years ago and it is beyond its labeled expiration date.
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
Biased results using vitros® chemistry products valp 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: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
After the installation of software version 3.1, customers reported they were unable to program a calibration for a uda as the reagent lot information is not available on their vitros 5,1 fs system.
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 received a report in which a philips efficia monitor (cm10/12/100/120/150) with lithium ion batteries that had exceeded its battery life expectancy and overheated/ignited.
these batteries should be replaced when the number of charge-discharge cycles exceed 300 cycles or or when the remaining battery capacity is below 80% of that of a new battery, whichever comes first.
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, http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01590-1
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Siemens healthcare diagnostics has identified an issue with millipore water purification module (wpm) progard pretreatment packs when used with the dimension vista triglyceride assay. an investigation by siemens identified the potential for patient and quality control (qc) triglyceride results to be erroneously elevated as a result of contamination introduced by the millipore progard pretreatment pack’s filter fibres.
a positive bias of up to 1.38 mmol/l has been observed.
the potential for falsely elevated results could occur when processing the triglyceride assay immediately following the change of the progard pretreatment pack in the millipore wpm.
siemens is not recommending a review of previously generated results.
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
Abbott has identified that the incorrect components, 2 assay diluent bottles (6c18j) or 2 pretreatment bottles (6c18x), may be present in a portion of batch 90059fn00.
kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (eg: error code 0900 or 0201).
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
Abbott has identified that the incorrect components, 2 assay diluent bottles (7k61j) or 2 pretreatment 1 bottles (7k61u), may be present in a portion of batch 91345ui00.
kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (eg: error code 0900 or 0201).
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 mr systems are standard equipped with two ceiling speakers, positioned in the front and/or rear of the mr system. these speakers enable communication between the operator in the examination room and the patient and offer stereo music or ambient experience audio.
these speakers are in most cases fixated in the suspended ceiling of the mr examination room according the philips service instructions. the philips planning reference data (prd) prescribes the suspended ceiling must be strong enough to hold 25 n speakers.
however in very rare cases, due to external influences (hospital facility maintenance, water leakage, degradation of speaker fixation) during the lifetime of the mr system, the ceiling speaker(s) could fall from their position and be pulled to the mr system by the magnetic field.
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 intermittent or permanent loss of ecg or spo2 monitoring may occur due to an issue with the patient cable. this may occur when using a carescape one monitor with a carescape ecg or carescape spo2 - masimo patient cable. no injuries have been reported due to this issue.
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 provides information about the new iv pole collar accessory for the trima accel system.
new trima accel systems will be shipped with an iv pole collar (see figure 1 in the attached fsn). this feature has been added to avoid a pinch point between the iv pole cross bar and the machine while lowering the iv pole. on new machines, the service technicians will attach the iv pole collar to the iv pole during installation.
if the operator does not hold onto the iv pole while pressing the iv pole release button, the iv pole may drop in a free fall. if the operator’s hand or any other body part is in the path of the free-falling iv pole, the operator could be injured. because this is an added safety feature, do not remove the collars after they are installed on the iv pole.