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.
The expiration date was extended by 20 weeks without justification.
Acción
An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records.
If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
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.
Extended expiration date; the product expired on february 12, 2009 but was labeled with a april 4, 2009 expiration date.
Acción
Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.
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
Anti-CD 45 antibody - Product Code NJT
Causa
Mislabeling: anti-cd45 cocktail antibody mislabeled as ki-67.
Acción
On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter.
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
Medical Cathode-Ray Tube Display - Product Code DXJ
Causa
Potential for monitor to shut down and not being able to power on again.
Acción
On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
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
Medical Cathode-Ray Tube Display - Product Code DXJ
Causa
Potential for monitor to shut down and not being able to power on again.
Acción
On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
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
Medical Cathode-Ray Tube Display - Product Code DXJ
Causa
Potential for monitor to shut down and not being able to power on again.
Acción
On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
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
intraocular lens - Product Code HQL
Causa
Abbott medical optics (amo) has received complaints of some tecnis 1-piece iols (model zcb00) have adhered to the lens optic after insertion into the eye. this can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.
Acción
Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA.
"THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY."
Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).
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
Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Causa
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Acción
The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.
Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.
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
Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Causa
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Acción
The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.
Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.
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
Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Causa
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Acción
The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.
Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.
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
Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Causa
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Acción
The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.
Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.
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
Calcium Reagent Set - Product Code CIC
Causa
Non-compliance with the good manufacturing practice regulations, as the manufacturing process for this product had not been validated.
Acción
Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
table for x-ray system - Product Code MQB
Causa
Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems.
due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
Acción
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
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
Photo Metric Method, Iron (non-heme) - Product Code JIY
Causa
Turbidity formation could occur, resulting in invalid test results being reported out.
Acción
Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product.
Please call 1-800-757-5313 if you have questions.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.