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
Catheter - Product Code GEI
Causa
Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
Acción
The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
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 Medical Accelerator - Product Code IYE
Causa
Erroneously resetting: rpm system version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. rpm 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the session options during the treatment session. this can lead to difference between the planned and delivered.
Acción
Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is 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.
Pump motor stall; pumps can stall due to gear shaft wear.
Acción
Begining August 3, 2007, consignees were notified by letter. The letter "Medtronic Urgent: Medical Device Correction Aug 2007" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.
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 Cutting Device - Product Code GEI
Causa
Device shut off/on: device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (patient burns may result from these device malfunctions).
Acción
Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a 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
Catheter - Product Code GEI
Causa
Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
Acción
The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
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
bone distractor - Product Code LXT
Causa
Markings reversed: graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
Acción
Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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.
Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or
dxc instruments have been related to an intermittent failure of the stirrer
motor.
-stirrer motors can stall without any flags or motion errors.
-if a stall occurs during a glum test near the time of sample inject,
results may be affected.
-affected glum results may be high or low.
Acción
GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
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
Hip Stem Protocol - Product Code LPH
Causa
Mis-labeling: an error on page 4 of the hipstar protocol was found. in the table for compatible heads, the 40 mm diameter heads with a neck length of +12 should have been omitted.
Acción
Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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
Femoral Stem - Product Code LPH
Causa
Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
Acción
Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.