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.
Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
Acción
Beginning on 2/19/04 the firm sent a letter dated 2/17/04 to customers via US Mail. The letter describes the malfunctions, how to avoid the malfunction and advises the customer they will be receiving a software upgrade which will resolve 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.
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.
A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.
Acción
A letter dated 3/15/04 was sent to each affected consignee, with labels included, requesting that they attach them to each affected bed.
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
Heart-Valve, Allograft - Product Code MIE
Causa
A retrospective review of donor files conducted by cryolife revealed an expired solution had been used during processing of the associated tissues.
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
Heart-Valve, Allograft - Product Code MIE
Causa
A retrospective review of donor files conducted by cryolife revealed an expired solution had been used during processing of the associated tissues.
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.
A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
Acción
The firm notified consignees by mail on 1/5/2004 and advised of potential for inaccurate power display when the device is actually transmitting. Consignees were requested to return the device for a software upgrade.
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
Giardia Spp. - Product Code MHI
Causa
False positive results.
Acción
Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
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
Cannula, Catheter - Product Code DQR
Causa
The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
Acción
Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
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
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Causa
Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the meridian.
Acción
Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2.
Baxter developed a permanent fix -- an enhanced air detector with improved sensitivity, making it capable of detecting air bubbles of a smaller size. Letters were sent to all Meridian customers on 7/11/05, informing them of the availability of the new detector and that a Baxter Field Service Engineer would contact them to schedule the upgrade.
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
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Causa
Software may cause instrument to omit step causing reagent carrover which may effect patient test result.
Acción
Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.
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
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Causa
Software may cause instrument to omit step causing reagent carrover which may effect patient test result.
Acción
Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.
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.
A software defect, relating to the motorized wedge functionality when using an elekta linear accelerator, can result in incorrect dose delivery to the patient. also, dose delivery in the wrong location may occur when using a elekta leksell headframe.
Acción
A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
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
Container, Sharps - Product Code MMK
Causa
The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.
Acción
Recall letters dated 2/25/04 requested the return of the product and providing for notification of the subaccounts that may have received the product.
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.
High bias noted in samples collected with edta. indication is to not run samples with edta.
Acción
Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
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
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Causa
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Acción
The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
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 was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
Causa
Kits containing 5 fr dilators may be labeled as 4 fr. kits containing 4 fr dilators may be labeled as 5 fr.
Acción
Letter dated 3/5/04 with instructions to return product.
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
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
Causa
Kits containing 5 fr dilators may be labeled as 4 fr. kits containing 4 fr dilators may be labeled as 5 fr.
Acción
Letter dated 3/5/04 with instructions to return product.
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.
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.
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.
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.
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.
A software defect, relating to the motorized wedge functionality when using an elekta linear accelerator, can result in incorrect dose delivery to the patient. also, dose delivery in the wrong location may occur when using a elekta leksell headframe.
Acción
A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
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.
A software defect, relating to the motorized wedge functionality when using an elekta linear accelerator, can result in incorrect dose delivery to the patient. also, dose delivery in the wrong location may occur when using a elekta leksell headframe.
Acción
A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
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.
A software defect, relating to the motorized wedge functionality when using an elekta linear accelerator, can result in incorrect dose delivery to the patient. also, dose delivery in the wrong location may occur when using a elekta leksell headframe.
Acción
A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
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
Heart-Valve, Allograft - Product Code MIE
Causa
Cryolife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to hcv (eia) in 1995.
Acción
Consignees were notified by telephone on 02/18/2004.