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.
Some units of trilogy shells manufactured since march 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). on 10/31/2012, the firm expanded the recall action to include lots of uni-hole trilogy acetabular system shells.
Acción
Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
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.
Some units of trilogy shells manufactured since march 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). on 10/31/2012, the firm expanded the recall action to include lots of uni-hole trilogy acetabular system shells.
Acción
Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
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.
Some units of trilogy shells manufactured since march 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). on 10/31/2012, the firm expanded the recall action to include lots of uni-hole trilogy acetabular system shells.
Acción
Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
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
Probe, radiofrequency lesion - Product Code GXI
Causa
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. the cannulas were not used on any patients, as the unsealed packages.
Acción
A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.
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
Stapler, surgical - Product Code GAG
Causa
Damage to the packaging may have compromised the sterility of the device.
Acción
On 10/28/2012, the firm sent Urgent: Device Recall, Event 5928 notification letters to their customers. The letters identified the affected product, the reason for the recall, the action to be taken by customers, as well as the actions taken by the firm. Customers are to examine their inventory immediately and remove the affected product. The Business Reply Form should be completed and faxed to Stericycle at 1-877-650-0360 within 3 business days, even if there is no affected product on hand. Customers must complete the "Replacement Purchase Order Number Field" on the Business Reply Form to ensure adequate identification of the return product in their facility. Customers should follow the instructions provided in order to return the product. The information should be shared with all appropriate staff at the customer's facility. EES planned to replace any unopened an unexpired recall product that was returned by December 31, 2012. Questions regarding the issue should be directed to Stericycle at 1-877-650-5412.
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
Lens, condensing, diagnostic - Product Code HJL
Causa
The defect was with mis-engraving of the lot # directly on the product and its packaging. mixed up device engraving of v20lc (lot # bb09213) with that from v60c (lot # bb09205).
Acción
Volk sent a Voluntary Medical Device Field Correction letter dated October 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were asked to correct their records with the correct lot number and to notify their customers of the voluntary field correction and request their compliance in updating their records. For questions customers were instructed to call 440-510-0800 or 440-942-6161.
For questions regarding this recall call 440-942-6161.
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.
This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
Acción
Synthes sent an Urgent: Medical Device Product Removal letter on September 7, 2012, to all affected consignees. Consignees were requested to immediately cease using the product, examine their inventory and remove the parts from inventory. If they had the parts, they were further instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the verification section at the end of the letter and return the verification form. If they did not have the parts, they were requested to complete the verification section at the end of the letter and return the verification form. Consignees with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
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
Bit, drill - Product Code HTW
Causa
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
Acción
OrthoHelix sent a "FIELD REMOVAL NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 330-247-1444 for questions concerning this notice.
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.
Firm initiated an update to directions for use necessitating replacement of previously distributed directions for use.
Acción
Instrumentation Industries, Inc. initiated a recall of this product on September 7, 2012 by sending a letter via priority mail to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to replace the package insert of any affected product with the enclosed corrected package insert (now at Rev. H). The Directions for Use can alsbe downloaded from their website if they should need additional copies. If the product was further distributed consignees were asked to notify their consignees about this Field Correction.
For questions regarding this recall call 412-854-1133.
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
Unit, x-ray, intraoral - Product Code EAP
Causa
There have been approximately 2% of the x-ray generators manufactured between february 2012 and november 2012 returned due to errors. these generators showed the type of defect that indicates poor contact of ht transformer power pin. the defect is a bent connector associated with the generator.
Acción
Trophy, A Carestream Dental Company, - A Subsidiary of Carestream Health Inc.
The Center for Devices (CDRH) understands that the corrective action plan (CAP) involving 167 units will consist of implementing rework procedure TL008, which describes the procedure for a bending the metallic strip the female connector to insure strong connection with the male counterpart.
The CAP appears to adequately address the problem and is hereby approved
For further questions please call (585) 781-1997.
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
Unit, x-ray, intraoral - Product Code EAP
Causa
There have been approximately 2% of the x-ray generators manufactured between february 2012 and november 2012 returned due to errors. these generators showed the type of defect that indicates poor contact of ht transformer power pin. the defect is a bent connector associated with the generator.
Acción
Trophy, A Carestream Dental Company, - A Subsidiary of Carestream Health Inc.
The Center for Devices (CDRH) understands that the corrective action plan (CAP) involving 167 units will consist of implementing rework procedure TL008, which describes the procedure for a bending the metallic strip the female connector to insure strong connection with the male counterpart.
The CAP appears to adequately address the problem and is hereby approved
For further questions please call (585) 781-1997.
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
It was found that there is a problem with the lcd monitor used in the console. the lcd monitor may
become blank during use. specifically, the backlight of the lcd monitor may turn off while the system
is in use, causing the lcd monitor to become blank. however, the other parts of the system continue to
operate normally, and the risk of a serious health hazard is therefore very low. the lcd moni.
Acción
Toshiba sent an Urgent Medical Device Correction letter dated October 1, 2012 via USPS return receipt mail to all affected customers . The letter identified the affected product, problem and actions to be taken. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions contact your local Toshiba representative at 800-521-1968.
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.
There is a potential loss of image(s) associated with the centricity to centricity (c2c) exam transfer module of centricity pacs system versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. when another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. once ter.
Acción
GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.
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.
Under certain conditions, when using the search functionality, the potential exists for the wrong patient's interactive documents to display when viewing a signed report in the single patient view. this can occur when the interactive document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. the notes viewer will.
Acción
Siemens Medical sent a Customer Safety Advisory Notice letter dated October 5, 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
There will be a Hot Fix available.
If you have any further questions please contact Siemens Customer Product Support at (1-888) 767-8326.
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.
Ge healthcare is aware of a potential safety risk where an image labeling situation exists in the image viewer software of the centricity cardio imaging product, version 5.0 sp1. multiple studies may be displayed side by side by selecting "compare study" from the study list, or by opening prior studies in the patient folder. in these cases, the viewer differentiates the studies wityh a label (curr.
Acción
GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future.
Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171.
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.
Ge healthcare has become aware of a software issue in your xeleris 2.1 workstation (that is used for processing discovery 530/570 data), that may impact patient safety.
on imported ct scans, myocardial perfusion imaging (mpi) studies may create artifacts in attenuation corrected images. this may lead to a potential for misdiagnosis.
Acción
GE Healthcare sent an Urgent Medical Device Correction letter dated October 5, 2011, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to contact their local GE Healthcare Service Representative if they have questions or concerns. They may also contact GE Healthcare Call Center , United States or Canada at 800-437-1171.
Other countries 262-896-2890.
For questions regarding this recall call 262-513-4122.
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
Unit, x-ray, intraoral - Product Code EAP
Causa
There have been approximately 2% of the x-ray generators manufactured between february 2012 and november 2012 returned due to errors. these generators showed the type of defect that indicates poor contact of ht transformer power pin. the defect is a bent connector associated with the generator.
Acción
Trophy, A Carestream Dental Company, - A Subsidiary of Carestream Health Inc.
The Center for Devices (CDRH) understands that the corrective action plan (CAP) involving 167 units will consist of implementing rework procedure TL008, which describes the procedure for a bending the metallic strip the female connector to insure strong connection with the male counterpart.
The CAP appears to adequately address the problem and is hereby approved
For further questions please call (585) 781-1997.
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
Unit, x-ray, intraoral - Product Code EAP
Causa
There have been approximately 2% of the x-ray generators manufactured between february 2012 and november 2012 returned due to errors. these generators showed the type of defect that indicates poor contact of ht transformer power pin. the defect is a bent connector associated with the generator.
Acción
Trophy, A Carestream Dental Company, - A Subsidiary of Carestream Health Inc.
The Center for Devices (CDRH) understands that the corrective action plan (CAP) involving 167 units will consist of implementing rework procedure TL008, which describes the procedure for a bending the metallic strip the female connector to insure strong connection with the male counterpart.
The CAP appears to adequately address the problem and is hereby approved
For further questions please call (585) 781-1997.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
As part of ge innova iq table introduction, a label was designed to be affixed on the front cover of the
gantry pivot section. this safety label is missing on systems manufactured between march 2010 and july 2011. in the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the c-arm gantry pivot and the head section of the table, there is a risk of co.
Acción
A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued.
For further questions please call (262) 513-4122.
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
Urinalysis controls (assayed and unassayed) - Product Code JJW
Causa
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. this results in the instrument not passing controls and the customer not being able to run patient samples.
Acción
IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.
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
Tray, surgical, instrument - Product Code FSM
Causa
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Acción
The firm, SpineFrontier, sent an Advisory Notice entitled "URGENT May 1, 2013, PedFuse Screw Caddy Removal" dated May 1, 2013 to their consignees/customers. The notice described the product, problem and action to be taken. Consignees/customers were informed that a removal has been initiated to remove the parts from the field to ensure that all sets contain correctly marked screw caddies. Consignees/customers wre instructed to complete and return the URGENT PedFuse Screw Caddy Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email: customerservice@spinefrontier.com. Replacement caddies will be shipped upon receipt of completed acknowledgement form and RMA request for part return.
Please feel free to contact SpineFrontier at 978-232-3990 with any 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.
Promotional literature for use of the da vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Acción
Intuitive sent a notification letter on October 17, 2011 by email to all consigness whose email address were on file. Also a copy of the letter was sent by registered mail on February 8, 2012 to all surgeons whose addresses were on file. The letters informed consignees that Intuitive Surgical were in the process of reviewing labeling for the da Vinci System in regard to use for thyroidectomy procedures. During this period, Intuitive will not provide or facilitate any promotional, training, case observations, proctoring or in case procedural support for use of the da Vinci System in conjunction with thyroidectomy procedures. The letters recommend consulting the institution policy regarding use of approved or cleared medical devices for procedures that are not specified in the labeled indication for use. Questions may be directed to customer service at 1-877-408-3872.
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.
Clarification of existing labeling and related cautions for the tip cover accessory of the da vinci surgical system.
Acción
Intuitive Surgical sent an Important Product Notification letters dated October 10, 2011 to all affected customers. A second letter was sent to those that had not responded on December 4, 2011. The letters identified the affected product, problem, and actions to be taken, The letter included recommendations and suggestions for proper use and prevention of damage to the Tip cover during surgery. Also attachments include recommendations and further information for the following areas: avoid instrument collisions; carefully install tip cover; straighten wrist prior to removal; inspect cannula prior to use and do not exceed maximum monopolar cautery settings.
Attached is a list of validated ESU settings and suggestions and instruction on being aware of critical anatomy in contact with the instrument and to change the tip cover in cases with extended cautery use.
Questions may be referred to Customer service at 1-800-876-1310 in the US and at + 41 21 821 2020 or +800-0821-2010.
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.
Clarification of existing labeling information and operating procedures.
Acción
Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.