U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Von Willebrand Factor-Immuno-Turbidimetric Assay - Product Code GGP
Causa
A dose-hook effect is observed starting from vwf:ag levels of 300%, while the package insert indicates that no dose-hook effect has been observed with vwf:ag levels up to 800%.
Acción
Customers were notified on March 13, 2007 by letter, first class mail.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
magnetic resonance imaging system with OR table - Product Code LNH
Causa
If table top is not seated properly it can lock up/stick.
Acción
The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code GIR
Causa
Stability of product not assured. an increase of clotting time for both normal and abnormal plasmas.
Acción
American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Power Wheelchair - Product Code ITI
Causa
Software error may permit the chair to recline too far.
Acción
The recalling firm sent a recall letter dated March 19, 2007. The recalling firm also posted information regarding the recall on their website.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code NHG
Causa
The test is not as sensitive, or as precise between runs, as claimed in the labeling. low concentrations are observed only in saliva samples.
Acción
The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Collimator - Product Code IZW
Causa
The collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. system is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 cfr.
Acción
Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Embolic Protection System - Product Code FRO
Causa
Insufficient wire sealing.
Acción
On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable defibrillator - Product Code NIK
Causa
Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
Acción
An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Patient Scale (Patient Lift) - Product Code FRW
Causa
Patient scale may become detached, which can cause a patient to fall and result in injury.
Acción
The scale manufacturer, IMS, in conjunction with the lift manufacturer, Joerns Healthcare (previously Sunrise Medical), will initiate a field fix strategy consisting of shipping replacement 4-point cradles without scales, for use until a replacement can be designed, tested and validated. Joerns will utilize their Customer Service Help Line (1-800-826-0270) on behalf of IMS, to inform customers of the voluntary field correction, address any questions regarding the IMS scale field fix strategy and to provide additional information on return of affected IMS Patient Scales.
Customers were notified by telephone beginning on January 30, 2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Digital Fluoroscopic Imaging - Product Code MQB
Causa
Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller, that may impact patient or staff safely.
Acción
Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Digital Fluoroscopic Imaging - Product Code MQB
Causa
Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller that may impact patient or staff safely.
Acción
Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Digital Fluoroscopic Imaging - Product Code MQB
Causa
Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller that may impact patient or staff safely.
Acción
Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code JJE
Causa
If the architect i2000/i2000sr system becomes contaminated with microbes generating folate-like by-products, the architect folate assay may experience calibration failures and/or shifts in results.
Acción
Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code JJE
Causa
If the architect i2000/i2000sr system becomes contaminated with microbes generating folate-like by-products, the architect folate assay may experience calibration failures and/or shifts in results.
Acción
Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.