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
Tibial Tray - Product Code JWH
Causa
Improperly machined parts: the cemented finned tibial trays could not seat the size 2 mating trial or polyethylene insert.
Acción
The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.
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
cardiovascular perfusion system - Product Code DTQ
Causa
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
Acción
A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
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
cardiovascular perfusion system - Product Code DTQ
Causa
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
Acción
A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
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
Occluder - Product Code MLV
Causa
Amplatzer pfo occluders were mislabeled with incorrect device sizes. the lot m06b01-58 contains 18mm pfo occluders but is labeled as containing 25mm devices. lot m06b01-52 contains 25mm pfo occluders but is labeled as containing 18mm devices. the affected product was not distributed within the united states and does not affect u.S. consignees.
Acción
Consignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices 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
extracorporeal oxygenator - Product Code DTQ
Causa
The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
Acción
U.S. consignees were visited by firm representatives between January 2004 and September 2005 and the device modified to correct the problem. Approximately 32 exported units are still in need of being upgraded.
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
cardiovascular perfusion system - Product Code DTQ
Causa
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
Acción
U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
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
cardiovascular perfusion system - Product Code DTQ
Causa
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
Acción
U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
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
Constant current stimulation unit - Product Code GWF
Causa
When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. this may result in a superficial burn on the patient if the stimulation is done for a long time.
Acción
All customers will be called by phone, then faxed the Product Notification starting 09/01/2006
Customers were instructed to indicate the serial numbers on each of your MS-210BK stimulators and fax the MS-210BK PRODUCT RECALLREPLACEMENT letter back to Nihon Kohden at: 949-580-15550 or email to customerservice@nkusa.com. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.
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
Flow Cytometry System - Product Code GKZ
Causa
Mis-identification-if a panel or protocol is added to an existing worklist but the tube location is not specified, the cxp acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a mis-identification condition.
Acción
Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.
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
cardiovascular perfusion system - Product Code DTQ
Causa
The battery status light on the front panel may not accurately reflect the actual status of the battery. the battery may contain more charge than indicated.
Acción
U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.
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
cardiovascular perfusion system - Product Code DTQ
Causa
The battery status light on the front panel may not accurately reflect the actual status of the battery. the battery may contain more charge than indicated.
Acción
U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.
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
Perfusion System - Product Code DTQ
Causa
The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
Acción
Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
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
Perfusion System - Product Code DTQ
Causa
The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
Acción
Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
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
X-ray system - Product Code JAA
Causa
Automatic exposure control (aec) automatically resets allowing another exposure without requiring manual reset as specified in 21 cfr 1020.31 (a)(3)(iv).
Acción
Correction to devices is being implemented through GEHC Field Modification Instructions.
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
Hemoglobin kit, in vitro diagnostic - Product Code JBD
Causa
The material used in packaging the product results in the presence of an additional artifact band above the hba fraction.
Acción
Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
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
Cardiac Septal Occluder Delivery System - Product Code GBK
Causa
Aga medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. these microscopic tears are a potential breach of the sterile barrier. aga has no confirmed complaints or adverse events related to this failure mode.
Acción
An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.
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
Cardiac Septal Occluder Delivery System - Product Code GBK
Causa
Aga medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. these microscopic tears are a potential breach of the sterile barrier. aga has no confirmed complaints or adverse events related to this failure mode.
Acción
An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.
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
Cardiac Septal Occluder Delivery System - Product Code GBK
Causa
Aga medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. these microscopic tears are a potential breach of the sterile barrier. aga has no confirmed complaints or adverse events related to this failure mode.
Acción
An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.
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
electrosurgical electrodes - Product Code JOS
Causa
Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.
Acción
The firm issued an ''Urgent: Device Recall'' notification to their customers via letter and E-mail on 8/29/2006 and 8/30/2006. The letter informs the customers of this problem and asks that the customers contact their sub-accounts and notify them of the problem if they have further distributed any of the suspect part numbers. The letter also asks that the distributor/customer(s) have the subaccounts discontinue use of the product; and return the held product to the distributor (who in turn, should return the product to Olsen Medical for reimbursement). The customers are asked to complete and fax back to the recalling firm, an attached Acknowledgement form documenting receipt of the recall notification by the customer/employee with name and date received. The firm also asked that the customer supply information regarding the amount of inventory /shipped on a checklist. The amounts received are broken down on the Checklist by Lot Number with the amount of product in inventory and the amount of product shipped. These amounts are reported by the responders by ''pieces and cases'' on hand at the time that the notice was received.
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.
Lifepak 20 may lock-up when attempting to power-up on dc within 2 seconds after removing ac power.
Acción
Letter dated December 2006 alerts users to the lock-up problem, and suggesting a procedure to prevent lock-up. Firm promised another letter in January 2007 detailing the plan to provide 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
Blood Gas Analyzer - Product Code JQP
Causa
Incorrect fi02 values: programming issue can cause incorrect values to be transmitted to the lis when : 1)- the fio2 result is edited in the manual sample processing mode--2)- an existing result is opened and fi02 is then edited and sent.....In both cases radiance will transmit the original fi02 value, not the value that was edited.
Acción
The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.
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
linear accelerator - Product Code IYE
Causa
The chain holding the device gantry in position may break.
Acción
On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
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
Automated slide stainer - Product Code KPA
Causa
Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
Acción
Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako.
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 shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation.
Acción
On 12/19/06 the firm sent letters via return receipt to all domestic customers. The letter advised customers of the issue and if the user encounters the problem, to press the button again with additional force. The users are to contact Philips for replacement. The devices can be used until the user receives a replacement.
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
dental handpiece accessory - Product Code EFA
Causa
End cap component can disassemble.
Acción
The recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.