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.
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems.
Acción
Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.
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
Change of level 3 error log messages to level 1 to prevent suspect assay results.
Acción
The recall was initiated by letter on March 22, 2004. The letter instructed customers regarding steps to change the error levels on each 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 was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
Marketed without pma or 510(k) approval.
Acción
Consignees were notified of the removal by phone on 3/10/04.
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
Marketed without pma or 510(k) approval.
Acción
Consignees were notified of the removal by phone on 3/10/04.
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, X-Ray, Angiographic - Product Code IZI
Causa
Unintended movements of both the c-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
Acción
Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.
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
Screen, Intensifying, Radiographic - Product Code EAM
Causa
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Acción
Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
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 was notified by the tennessee department of health, that a recipient had contracted a group a streptococcus infection from orthopedic tissue originating from the same donor as cryolife donor 69347.
Acción
The consignee was contacted by telephone by the CryoLife Medical Director on 01/30/2004.
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
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.
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
Lipoprotein, Low-Density, Antigen, Antiserum, Control - Product Code DFC
Causa
Assay result not consistent with the assigned control value.
Acción
On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests 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.
Notas adicionales en la data
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
Air may be introduced into this stent system when used with certain size acessory devices.
Acción
On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling.
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
Software coding error may cause a fatal error message.
Acción
Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
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
Lift, Patient, Non-Ac-Powered - Product Code FSA
Causa
The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
Acción
All affected end users were given a copy of the Customer Advisory Notice dated 1/30/03, during the Arjo salesmen visits to inspect the Minstrel lifts for the presence of the tension pin in the pivot bolt of the lift. The advisory informed the user of the incident where the spreader bar detached from the scale unit. The end user was requested to read the advisory and sign the bottom portion of it certifying that they read the advisory and that the Arjo salesman inspected their units for the presence of the tension pin, retaining a copy of the signed advisory notice and the inspeciton record.
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
Screen, Intensifying, Radiographic - Product Code EAM
Causa
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Acción
Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
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
Screen, Intensifying, Radiographic - Product Code EAM
Causa
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Acción
Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
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
Screen, Intensifying, Radiographic - Product Code EAM
Causa
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Acción
Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
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
Counter, Differential Cell - Product Code GKZ
Causa
If a customer enters a dilution factor for sample b prior to the results from sample a being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the sample a's results once they are received at the workstation.
Acción
A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 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
System, X-Ray, Angiographic - Product Code IZI
Causa
Unintended movements of both the c-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
Acción
Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.
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, X-Ray, Angiographic - Product Code IZI
Causa
Unintended movements of both the c-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
Acción
Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.