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
hospital bed - Product Code FNL
Causa
The brakes may not have adequate holding power to lock the bed in place.
Acción
Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct 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
Reservoir Bag - Product Code BTC
Causa
Separation from bushing: the breathing bag may separate from the bushing during use.
Acción
Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.
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
Reservoir Bag - Product Code BTC
Causa
Separation from bushing: the breathing bag may separate from the bushing during use.
Acción
Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.
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 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 data.
Notas adicionales en la data
Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Canine and equinine Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Canine and equinine Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Devices have the potential to electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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
Reservoir Bag - Product Code BTC
Causa
Separation from bushing: the breathing bag may separate from the bushing during use.
Acción
Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.
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 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 data.
Notas adicionales en la data
Muslce stimulator and therapeutic ultrasound with electromyography - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator with electromyography - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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 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 data.
Notas adicionales en la data
Muscle stimulator and therapeutic ultrasound - Product Code MPH
Causa
Device malfunction: causing electric shock and burn.
Acción
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
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.
Incorrect display: in certain modes, the protocol will not initially display the correct data in some plots. in addition, when running ewl files, any edited sampleid1 is not automatically updated in all tubes in the panel.
Acción
Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
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.
Incorrect display: in certain modes, the protocol will not initially display the correct data in some plots. in addition, when running ewl files, any edited sampleid1 is not automatically updated in all tubes in the panel.
Acción
Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
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.
Incorrect display: in certain modes, the protocol will not initially display the correct data in some plots. in addition, when running ewl files, any edited sampleid1 is not automatically updated in all tubes in the panel.
Acción
Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
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
Medication Cassette Reservoirs - Product Code FRN
Causa
Leakage associated with the cadd medication cassette reservoirs for use with the cadd ambulatory infusion pumps.
Acción
Consignees were mailed the recall letters on December 21,2007. The recalled letter "Smiths Mecical Urgent Product Recall Notification" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical.
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
Medication Cassette Reservoirs - Product Code FRN
Causa
Leakage associated with the cadd medication cassette reservoirs for use with the cadd ambulatory infusion pumps.
Acción
Consignees were mailed the recall letters on December 21,2007. The recalled letter "Smiths Mecical Urgent Product Recall Notification" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical.