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.
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 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
The csf gels were manufactured incorrectly resulting in irregular wavy bands.
Acción
The firm contacted the consignee by telephone on 5/16/2002.
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
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the r1 reagent is depleted.
Acción
Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.
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.
Recall letter was sent on 2/10/2003 to Zimmer Patient Care Division. The letter states that Zimmer is to conduct a sub-recall to their customers to account for the 127 pieces sent to them.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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
Device, Digital Image Storage, Radiological - Product Code LMB
Causa
Imaging archive system software mismatches images and patient names.
Acción
Recall letters were sent March 11, 2003. Another mailing was sent March 26, 2003 with stickers and preventative practice suggestions. A software fix will be available to customers in the near future.
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
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 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
Microorganisms were detected in associated allografts after initial release of donor.
Acción
The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
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
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.
Notas adicionales en la data
Radioimmunoassay, Estradiol - Product Code CHP
Causa
Short volume, resulting possibility of falsely elevated results.
Acción
Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
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.
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Acción
An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.