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
Bur, surgical, general & plastic surgery - Product Code GFF
Causa
Anspach was contacted by a hospital to inform anspach that a blackmax motor had been used in a case where the patient was diagnosed with creutzfeldt-jacob disease (cjd).
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.
Integra became aware through a complaint from a single non-us customer that if the optional sys/dias mode is used on cam01 monitor that contains mod 4 firmware, the displayed values for the systolic and diastolic intracranial pressure (icp) are reversed. but, if the cam01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.
Acción
Integra sent an Urgent Medical Device Correction letter and Correction Acknowledgement form dated November 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Our records indicate that you received one or more of the affected serial numbers that will require this firmware update. Integra asks that you do the following:
1. Review your inventory and verify that you have Camino Advanced Monitors with a serial
number formatted as MExxxxxx04. If so, you can continue to use the CAM01
monitor(s), being aware that if you choose to use the optional SYS/DIAS mode, the
values on the CAM01 display will be reversed.
2. Complete the attached form. If you do not have the product with the affected serial
number in service at your facility, check the box:
I do not have any product with a serial number of the form MExxxxxx04.
3. If you do have the affected serial number, check the box:
I do have the product with a serial number of the form MExxxxxx04, and please
indicate the serial numbers you have.
4. Complete the other information and return it by email or fax as indicated on the form.
Complete the form and return it by email or fax as indicated on the form.
Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723.
We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
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
Cannula, injection - Product Code FGY
Causa
Bd interlink threaded lock cannula ref# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
Acción
BD Diagnostics sent an Urgent: Voluntary Product Recall letters/Notice of Return dated November 26, 2013, to all affected customers. Customers were asked to identify and segregate stock of the affected number, inform the appropriate personnel in their organization to discontinue use of the affected product, return the afected product, following the instructions on the enclosed packing slip, BD would issue a credit for product returned. If product was further distributed customers were instructed to identify their customers and notify them at once of the product recall using the provided customer communication. Customers were asked to complete the attached notice and fax to 855-731-0157. Customers with questions were instructed to call 1-855-731-0157.
For questions regarding this recall call 755-731-0157.
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
Compressor, air, portable - Product Code BTI
Causa
Maquet compressor mini may deliver compressed air at a temperature higher than specified.
Acción
Maquet sent a product recall urgent-medical device field correction letter/customer fax response via Fed Ex on December 5, 2013, to their customers.
Customers are advised of the issues with the device and provided instructions. The correction will include an update with replacement of the affected connector and if needed replacement of the thermoelectric cooler if it damaged. These operations will be performed by an authorized Maquet representative. Any questions can be directed to customer service at 1-888-627-8383 option 2 followed by option 3 Monday through Friday between the hours of 8 am and 6 pm EST.
Customers should completed and return the enclosed confirmation form or scan a copy to field actions@maquet.com or fax (973) 807-9290.
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
Susceptibility test discs, antimicrobial - Product Code JTN
Causa
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Acción
Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it.
If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).
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
Sterilization wrap containers, trays, cassettes and other accessories - Product Code KCT
Causa
The quad-lock sterilization container system may not maintain an effective sterile barrier.
Acción
The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical.
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
Ventilator, continuous, facility use - Product Code CBK
Causa
Covidien is conducting a voluntary field corrective action on puritan bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code xb0069 in which the device stops mechanical ventilation due to a software error.
Acción
Covidien sent an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue using their Puritan Bennett 840 ventilators until it is feasible to install the software update discussed in the letter. Covidien has developed a software solution to address this issue. Upon availability, there will be several ways to install the software update. To initiate the process for updating your software and to select the method that best suits your facility, please visit our software update management portal at www.PB840technicalupdate.com and follow the instructions to register your ventilators. If you need further assistance contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1.
For questions regarding this recall call 800-255-6774.
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 recently become aware of a potential safety issue due to intermittent failure of the spring loaded
mounting latch of pdms produced from april 2007 through december 2012.
Acción
The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 26, 2013 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees/customers were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will provide a new latch at no charge once it is available. GE will contact you to arrange for installation of the latch.
If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044, or your local 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.
Navilyst medical has recalled a port kit with access infusion set due to a possible breach of sterilization barrier.
Acción
Navilyst Medical, Inc., sent an Urgent Medical Device Recall - Immediate Action Required letter dated November 25, 2013 to their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers are instructed to segregate and return all affected devices to Navilyst Medical, Inc. Distribution Center Attn: QA Returns 10 Glens Falls Technical Park Glens Falls, NY 12801 and complete and return the Reply Verification Tracking Form provided in the recall notification via Fax to: 1-800-782-1357. For questions call 1-800-833-9973 between 8:30 am and 7:00 pm (EST).
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
Toothbrush, powered - Product Code JEQ
Causa
Ranir, llc is recalling all lots of up & up brand kid's power toothbrush and topcare brand clifford kids power toothbrush because the tufted disk may become detached from the power brush handle. if the
tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Acción
Ranir, LLC phoned their two direct accounts notifying them of this recall on December 12, 2013. On December 18, 2013, Ranir, LLC sent an URGENT: MEDICAL DEVICE RECALL notification letter was sent to their direct accounts. The notification stated the affected product, issue, and instructions for responding to the notification, including instructions for return of the affected product. Questions are directed to Paula Bojsen (616)698-8880.
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
Toothbrush, powered - Product Code JEQ
Causa
Ranir, llc is recalling all lots of up & up brand kid's power toothbrush and topcare brand clifford kids power toothbrush because the tufted disk may become detached from the power brush handle. if the
tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Acción
Ranir, LLC phoned their two direct accounts notifying them of this recall on December 12, 2013. On December 18, 2013, Ranir, LLC sent an URGENT: MEDICAL DEVICE RECALL notification letter was sent to their direct accounts. The notification stated the affected product, issue, and instructions for responding to the notification, including instructions for return of the affected product. Questions are directed to Paula Bojsen (616)698-8880.
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.
Missing screws in the overhead video monitor suspension. ge discovered that the 4 outer screws that hold the overhead video monitor suspension to the carriage were missing since installation of the system. ge is not aware of any fall of the overhead monitor suspension.
Acción
GE Healthcare Systems sent an " Urgent Medial Device Correction" letter dated November 7, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology /Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (USA 800-437-1171, Japan 0120-055-919, For other countries, please contact your local GE Healthcare 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.
Notas adicionales en la data
Couch, radiation therapy, powered - Product Code JAI
Causa
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 txt treatment table. combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the txt" treatment table has been damaged due to contacting a moving part. the resulting short-circuit cau.
Acción
The firm, Siemens, sent a "Medical Device Correction" letter to affected users/customers starting on December 5, 2013 via Federal express. The letter described the product, problem and actions to be taken. Siemens has arranged for modification of the affected 500 TxT Treatment Table. A service representative will modify the mounts of the TT-A, TT-D, TT-M, or TT-s table tops ( Pleases note that this modification only applies to the Siemens provided table tops TT-A, TT-D, TT-M, and TT-S.). In addition, the Siemens service representative will modify the cable routing inside of the patient table base. The customers were instructed to include this Field Safety Notice in your Digital Linear Accelerator System Owner manual chapter 'Safety Advisory Letters' where it should remain.
If you have any questions, please contact the Senior Manager, Regulatory Affairs at 1-925-293-5442 or email: christine.dunbar@siemens.com.
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.
Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received 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.
Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received 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
Camara, x-ray, fluorographic, cine or spot - Product Code IZJ
Causa
The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (pm) may not detect small cracks or deficiencies in the fork weldment.
Acción
On October 30, 2013 & December 4, 2013, the firm sent Urgent Medical Device Recall letters to their 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
Portable oxygen Generator - Product Code CAW
Causa
Heat exchanger hose becomes weak and may fail.
Acción
On Site Gas Systems issued letter on 12/19/13 and stated replacement parts to retrofit the blue Federal Heater hose with stainless steel will be provided and the letter included the Technical Bulletin TB 12-19-13-1 .
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.
Anspach was contacted by a hospital to inform anspach that a blackmax motor had been used in a case where the patient was diagnosed with creutzfeldt-jacob disease (cjd).
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
Multi-analyte controls, all kinds (assayed) - Product Code JJY
Causa
Horiba medical is informing all abx pentra urine control l/h customers running the creatinine assay
on abx pentra chemistry analyzers that the target range for creatinine has been updated. the abx pentra urine control l/h lot specific annexes have been updated to
include revised acceptable target ranges for creatinine.No other analyte values
are affected.
Acción
HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target
Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative.
For questions regarding this recall call 949-453-0500.
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, continuous flush - Product Code KRA
Causa
Merit medical systems, inc. is conducting a recall for 3 lots of maestro microcatheters with a graphic
discrepancy on the carton/box label end panel. the catheter graphic on the front of the carton
box (correct) and the graphic on the end panel (incorrect) do not match.
Acción
Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062.
For questions regarding this recall call 801-253-1600.
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.
Advia centaur¿ systems phenytoin calibrator n,
lots cn58 and higher, change in recovery observed with the advia centaur systems phenytoin assay compared to recoveries using previous calibrator n lots.
Acción
Siemens Healthcare Diagnostics Customer Notification notice was sent to affected Siemens Healthcare Diagnostic customers in the United States on December 18, 2013.. The notifications inform customers that Siemens Healthcare Diagnostics received customer feedback regarding the performance of the ADVIA Centara¿ Systems Phenytoin assay, indicating that the assay was recovering higher relative to the performance of other assays in proficiency studies. Siemens internal investigation confirmed the positive bias for Calibrator N lot CN 57 in the ADVIA Centaur Systems Phenytoin assay. This lot has expired and is no longer in use. Expected performance has been restored starting with Calibrator N lot CN58. Siemens is notifying customers that have received Calibrator N lots CN58 and higher that there will be a change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens is providing data to inform customers of the expected difference between Calibrator lots CN58 and higher versus prior Calibrator N lots.
Customers were instructed to retain the letter with their laboratory records, and forward to those who may have received the affected product.
Customers with questions were instructed to contact their Siemens Customers Care Center or their local Siemens technical support representative.
For questions regarding this recall call 508-668-5000.
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
System, x-ray, mobile - Product Code IZL
Causa
There exists a software issue associated with patient selection from the worklist on the optima xr200 with digital upgrade, and optima xr220amx mobile x-ray systems. intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the mobile x-ray system are not properly displayed. if the user continues to attempt to select one of the exams w.
Acción
GE sent an Urgent Medical Device Correction letter, dated 11/7/2013 to consignees. The letter described the issue, identified devices affected and stated that users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. The user may also confirm during the exam that the appropriate patient information was selected via the display on the upper left portion. GE will fix the units with a software fix at no 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
System, x-ray, tomography, computed - Product Code JAK
Causa
During clinical operation, a malfunction may occur causing a system display freeze with somatom definition, definition as, and definition edge while running software version syngo ct2012 b and syngo ct2013b.
Acción
A recall notification letter, dated November 15, 2013, was sent to Users.
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, biliary, diagnostic - Product Code FGE
Causa
Extractor pro xl retrieval balloon catheters may have the incorrect skive hole location or balloon size.
Acción
Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory.
For questions regarding this recall call 508-382-9555.
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
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter - Product Code FGE
Causa
Extractor pro xl retrieval balloon catheters may have the incorrect skive hole location or balloon size.
Acción
Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory.
For questions regarding this recall call 508-382-9555.