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
Screwdriver - Product Code HXX
Causa
Greatbatch medical has initiated a global field recall
for torque limiting devices. greatbatch identified through laboratory testing that the required sterility assurance level (sal) of 10-6 is not
achieved on torque limiting devices when subjected to steam sterilization cycles identified in the instruction
for use (ifu) provided with the device.
Acción
Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.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.
Notas adicionales en la data
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Causa
Greatbatch medical has initiated a global field recall
for torque limiting devices. greatbatch identified through laboratory testing that the required sterility assurance level (sal) of 10-6 is not
achieved on torque limiting devices when subjected to steam sterilization cycles identified in the instruction
for use (ifu) provided with the device.
Acción
Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.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.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
Potential non-recoverable loss of image acquisition.
the affected discovery systems may experience multiple x-ray abort errors before or during a real-time fluoroscopic interventional procedure.
Acción
Consignees were sent on 4/15/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 2016. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 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.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
Potential non-recoverable loss of image acquisition.
the affected discovery systems may experience multiple x-ray abort errors before or during a real-time fluoroscopic interventional procedure.
Acción
Consignees were sent on 4/15/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 2016. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 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.
Notas adicionales en la data
Ureteroscope and accessories, flexible/rigid - Product Code FGB
Causa
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.G., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Acción
Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
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
Ureteroscope and accessories, flexible/rigid - Product Code FGB
Causa
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.G., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Acción
Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
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
An out of tolerance torque tool was used on three joints during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Acción
GE Healthcare Systems sent an Urgent Medical Device Correction letter dated April 20, 2016, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
For questions contact GE Healthcare Service at 1-800-437-1171 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.
Notas adicionales en la data
Orthopedic Screwdriver - Product Code HXX
Causa
There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Acción
Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.
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.
During a recent ohio site inspection by the fda it was discovered that warning statements needed to be included with the product shipment.
Acción
A letter dated April 14, 2016 was sent to customers. The letter stated the reason for the recall. It also informed customers that there is no impact on the performance of the assay. Customers were asked to either visit the IVD web portal (www.affymetrix.com/ivd) and review the warning statements; or, request a hard copy free of charge.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm sent out customer notification letters on 04/28/16.
Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed.
Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found.
Please return the completed and signed Recall Effectiveness Check Form to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com
or mail to:
Stryker Sustainability Solutions
1810 West Drake Drive
Tempe, AZ, 85283
Attn: Jodie Rueckert
If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned.
Adverse reactions or quality problems experienced with the use of this product
may be reported to:
- Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433
X5555
- http://www.stryker.com/productexperience/
- The FDAs MedWatch Adverse Event Reporting program either online,
by regular mail, or by fax.
On 05/12/16 the firm sent out a clarification letter to emphasize that use of affected lots of product should be discontinued. In addition, SSS would like to note that, use of devices larger than expected may result in excess force applied to the blood vessel. The risk to the patient can vary from a prolongation in procedure time, vessel rupture, organ damage or other unforeseen consequences. Some of these injuries may require surgery or other procedures to remedy. Any questions contact the Stryker Sustainability Solutions Sales Representative or Regulatory Affairs.
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.
Volcano has become aware of an incompatibility issue between impacted systems and hospital network scans. in specific circumstances, an impacted system will encounter unexpected data from the hospital network and be forced to reboot.
Acción
The firm, Philips, sent an "URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated 4/25/2016 to its customers beginning April 29, 2016 which include a technical service bulletin to explain how to assure the incompatibility issue does not affect system performance. The customers were instructed to do the following:
-If you have an Impacted System but it is not connected to a network, this issue does not affect your system. Additionally, if network scans are not performed, this issue does not affect your system.
-If you have an Impacted System that is connected to a network and staff performs network scans while the Impacted System is in operation, this issue does affect you and the circumstances exist for a manual reboot to occur during an active procedure. To avoid this, the following corrections must promptly be taken: 1. Disconnect your Impacted Systems from the facilities network. If you need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; OR 2. Do not permit your staff to perform network scans while the Impacted Systems are in operation.
-Please complete, sign, and return the attached form indicating that you received this Field Corrective Action notification via Fax to Volcano Customer Service at (916) 638-8812 or email to CS@volcanocorp.com.
If you have any questions, please call (800) 228-4728, option 5.
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
Colonoscope and accessories, flexible/rigid - Product Code FDF
Causa
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Notas adicionales en la data
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Notas adicionales en la data
duodenoscope and accessories, flexible/rigid - Product Code FDT
Causa
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Notas adicionales en la data
Set, i.V. Fluid transfer - Product Code LHI
Causa
Bbmi recently identified a potential for a tear in the outer blister packaging on a limited number of units. the tears have been identified in the blister package paper, where the unit label writing is located.
Acción
B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: PA_QualityAssurance.BBMUS_Service@bbraun.com and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.
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
Set, i.V. Fluid transfer - Product Code LHI
Causa
Bbmi recently identified a potential for a tear in the outer blister packaging on a limited number of units. the tears have been identified in the blister package paper, where the unit label writing is located.
Acción
B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: PA_QualityAssurance.BBMUS_Service@bbraun.com and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.
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
Colonoscope and accessories, flexible/rigid - Product Code FDF
Causa
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Notas adicionales en la data
sigmoidoscope and accessories, flexible/rigid - Product Code FAM
Causa
Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
Acción
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.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.
Notas adicionales en la data
Test,natriuretic peptide - Product Code NBC
Causa
Due to a packaging error; the kit does not contain the correct number of c1 or c2 control vials.
Acción
bioMerieux. sent an Urgent Product Removal Notice letter dated April 26, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check for affected products in their inventory and discard the incomplete products. Customers were asked to complete the attached Acknowledgement Form and return it via fax to bioMerieux. For questions contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666.
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
Radioimmunoassay, human growth hormone - Product Code CFL
Causa
24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (lgfa) contained in the kit.
Acción
On April 15, 2016, Siemens Healthcare Diagnostics Inc. distributed Urgent Medical Device Correction notices to their domestic customers and Urgent Field Safety Notices to their internationally customers via courier service. Customers are advised to take the following four actions: 1) To continue using IGF-I kit lot 411 and the associated pretreatment solution lot 055 to report patient results, ensure the IGF-I pretreatment solution is allowed to incubate with the patient sample for a minimum of 24 minutes prior to processing on the IMMULITE/IMMULITE 1000 systems. 2) Complete and return the Effectiveness Check Form attached to the letter within 30 days. 3) Please review the letter with your Medical Director. 4) If you have received any complaints of illness or adverse events associated with the product, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. If customers have further distributed the product, please retain the letter with your laboratory records, and forward to those who may have received this 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
Gauze/sponge, internal, with drug/biologic, animal source material - Product Code GEL
Causa
Ethicon is recalling evarrest fibrin sealant patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the fibrin patch units instead of the valid expiration date (2016-12-28).
Acción
Ethicon sent an "Urgent: Product Recall (Removal)," dated April 14, 2016 via UPS next day mail to their affected customers. The letter identified the affected product and the reason for the recall. The letter also states that product from the affected lot is still within the expiration date, and health care practitioners, who have treated patients with the product should continue to follow patients in the usual manner. Users are to examine their inventory and quarantine the affected product. The affected product should be returned per the instructions outlined in the letter. Ethicon will provide replacement product upon receipt. Customers are to complete and return the Business Reply Form. If customers need assistance returning the product, they can contact Stericycle at 1-866-761-9472. If there are questions regarding the replacement product, customers can contact Ethicon Customer Support Center at 1-877-ETHICON.
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, phacofragmentation - Product Code HQC
Causa
Alcon is conducting this voluntary medical device removal for specific lots of its centurion fms packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
Acción
The affected consignees were sent a recall notification letter on 4/28/16.
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
Device, pasteurization, hot water - Product Code LDS
Causa
The replacement hepa filters have been manufactured with sealant that may not be properly cured. improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the sterile drier and its contents.
Acción
Natus sent an " URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 2016) was sent to all affected customers on May 2, 2016. for the first set of customers and then sent on May 12, 2016, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter " if the serial number is one of the 21 shown as affected serial numbers on the letter.
The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 2016 and released on May 12, 2016,) was sent to customers on May 16, 2016, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier " if it contains a HEPA filter that is identified with one of 21 affected serial numbers.
Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber.
Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter.
Please contact Natus at Seattle_Technical_Service@natus.com or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.
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.
Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to regulatoryaffairs@toshiba.com. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.