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
Cell Differential Counter - Product Code GKZ
Causa
Incorrect results: hemoglobin results in donor samples assayed on the cell-dyn 1800 system vary more than expected across the range of claimed operating temperatures of 18 degrees celcius to 30 degrees celcius.
Acción
A Product Correction letter was sent to all customers with a reply form on October 27, 2006. Product information letters are being packed with the instrument's accessory kit and with calibrators and quality control products used with the CELL-DYN 1800 System. Correction letters with reply forms have been resent to nonresponding 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
Knee Femoral Component - Product Code JWH
Causa
Loose fixation pegs: one lot of femoral components may have loose fixation pegs.
Acción
Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of 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
electrosurgical pencil - Product Code GEI
Causa
Packaging weakness may compromise sterility and instructions for use are inadequate.
Acción
Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return 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
defibrillator control board - Product Code MKJ
Causa
Inadequate shipping package causing damage to control boards resulting in unit failure. failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the pcb assembly.
Acción
Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.
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
Computed Tomography X-Ray System - Product Code JAK
Causa
Incorrect measurement: incorrect measurement will occur when the operator uses the distance or area measurement function, such as graphic tool line or roi on zoomed and batch saved images from the cardiac viewer or pulmonary viewer and then views them in the ct viewer or on a pacs system.
Acción
Consignees were notified of this recall by an Urgent Device Notification letter sent on 9/10/07. The letter instructed the users to not save any zoomed images to a batch file. Make all measurements of zoomed images in the CT viewer, which provides correct measurements. Do not perform measurements on any zoomed batched images that have been stored on a PACS System. Phillips in investigating the problem and will provide updates free of charge when completed.
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
Computed Tomography X-Ray System - Product Code JAK
Causa
Incorrect measurement: incorrect measurement will occur when the operator uses the distance or area measurement function, such as graphic tool line or roi on zoomed and batch saved images from the cardiac viewer or pulmonary viewer and then views them in the ct viewer or on a pacs system.
Acción
Consignees were notified of this recall by an Urgent Device Notification letter sent on 9/10/07. The letter instructed the users to not save any zoomed images to a batch file. Make all measurements of zoomed images in the CT viewer, which provides correct measurements. Do not perform measurements on any zoomed batched images that have been stored on a PACS System. Phillips in investigating the problem and will provide updates free of charge when completed.
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
Tracheostomy Tube - Product Code JOH
Causa
Mislabeled. the product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
Acción
Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
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
Steris Quick Connects - Product Code MED
Causa
Loose or missing adaptor: the center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. the absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.
Acción
STERIS has contacted affected direct accounts by phone to notify direct accounts of the recall. On 9/28/2007, STERIS will mail a recall notification to all affected direct accounts via certified mail. The notification informs direct accounts that STERIS representatives will be visiting direct accounts to retrieve affected products and provide replacements. Where direct accounts further distribute, STERIS representatives will inform the direct accounts to contact their sub-accounts and facilitate exchange of affected product for replacement product. Replacement product will be available beginning November 1, 2007.
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
Electrocardiograph - Product Code DPS
Causa
Incorrect display: when using the 16 lead patient interface module (pim), lead tracings of v3r and v4r are reversed in the extended lead modes of pediatric and balanced.
Acción
Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.
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
Spinal Implant Component - Product Code KWP
Causa
Assembly may be compromised: two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
Acción
Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.
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-HBc IGM EIA kit, - Product Code LOM
Causa
Incorrect instruction: the package insert states to add 100l of conjugate; it should state to add 100ul.
Acción
On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
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 Fixation Plate - Product Code HRS
Causa
Seat/fit problems: the heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
Acción
On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix 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
ultrasound scanner - Product Code IYN
Causa
Inaccurate guidelines: the be9c is an optional, small radius bi-planar convex probe intended for use with the logiq 3 expert system in urology application. an attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. the incorrect guidelines are recognized by their orientation that is left/right reversed from t.
Acción
GE sent consignees a "GE Urgent Medical Device Correction" letter dated 8/14/07. The letter informed the customers about the problem, offer a short-term workaround and informed them that a representative will schedule a visit to upgrade the software.
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
Cement Gun - Product Code LXH
Causa
Loose screw component: a screw may come loose and fall from the device during use, and result in implantation with the bone cement.
Acción
Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.
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
Cement Gun - Product Code LXH
Causa
Loose screw component: a screw may come loose and fall from the device during use, and result in implantation with the bone cement.
Acción
Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.
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
Guide Catheter - Product Code DQY
Causa
Missing holes: catheters are missing the catheter's side holes.
Acción
A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping 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
Guide Catheter - Product Code DQY
Causa
Missing holes: catheters are missing the catheter's side holes.
Acción
A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping 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
lead test in vitro diagnostic - Product Code DOF
Causa
Level 1 and level 2 control values were incorrectly assigned.
Acción
ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial
label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.
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
lead test in vitro diagnostic - Product Code DOF
Causa
Level 1 and level 2 control values were incorrectly assigned.
Acción
ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial
label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.
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
Tomography System (Emission Computed) - Product Code KPS
Causa
Unintended motion: a hardware fault in the c.Cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
Acción
Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens office at: 1-800-888-7436 (USA).
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
apheresis system, a blood component separator - Product Code LKN
Causa
Under specific conditions, apheresis machine could return up to 60ml of air to the patient.
Acción
All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the 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
Single Use Mechanical Lithotriptor - Product Code LQC
Causa
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
Acción
The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.
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
Single Use Mechanical Lithotriptor - Product Code LQC
Causa
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
Acción
The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.
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
Single Use Mechanical Lithotriptor - Product Code LQC
Causa
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
Acción
The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.
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
Single Use Mechanical Lithotriptor - Product Code LQC
Causa
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
Acción
The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.