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
Bed, Air Fluidized - Product Code INX
Causa
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
Acción
In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
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.
Electrical failure of the bed due to fluid egress into the junction box.
Acción
In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of 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.
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
Ultrasound imaging system - Product Code IYO
Causa
Improperly terminated wires on a component of the ilab acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.
Acción
On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.
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.
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
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.
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
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.
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
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.
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
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.
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
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
Causa
Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
Acción
A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for 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
Causa
Instructions for use contained incorrect sensor reference.
Acción
A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
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
Causa
Instructions for use contained incorrect sensor reference.
Acción
A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
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
Causa
Instructions for use contained incorrect sensor reference.
Acción
A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
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
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Causa
Ict assays run using a manual dilution will not be calculated correctly by the software.
Acción
Product Information letter dated 29 December 2000 was sent to all AEROSET 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
pathology lab software - Product Code JQP
Causa
The client had made a decision to use the softpath module in a nonstandard manner. under specific circumstances, incorrect text may appear on a patient report.
Acción
The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
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
Cord, Electric, For Endoscope - Product Code FFZ
Causa
An incorrect electrosurgical cord was included in some of the packages.
Acción
Consignees were notified by letter sent Federal Express on 01/25/2001.
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
Causa
Wrong connector attached to blood pressure cuff.
Acción
The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of 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.
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Catheter does not fit through the needle resulting in delay of medical procedure.
Acción
The firm initiated the recall via letter to all consignees on May 9, 2001.
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
Ventilator, Continuous, Facility Use - Product Code CBK
Causa
Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
Acción
Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
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
unknown device name - Product Code CPK
Causa
Material hardness on original design check valve may cause premature failure.
Acción
Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
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.
Notas adicionales en la data
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Causa
Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
Acción
Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.
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
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Causa
Extensive use of cuvettes causes inaccurate results. preventative maintenance did not specify replacement schedule.
Acción
The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
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
Causa
These catheters have j-shape tips instead of the labeled mp (multipurpose) tips and also are packed into the incorrect tip tray.
Acción
The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.