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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
Acción
The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update.
If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
Acción
The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update.
If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
Acción
The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update.
If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
Acción
The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update.
If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
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 circumstances the patient
demographics in a report exported into the emr may not match the demographics shown in the corresponding synapse cv clinical report.
Acción
Fujifilm Medical on 2/4/14 , contacted users and advised to discontinue using HL7 reports pending FMSU determination of root cause. Firm issued follow-up letters on 2/24/14 and 7/24/14 advising users of a mandatory upgrade to version 5.1.1 I base, in-place upgrade, to correct the problems.
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.
Measurement values in the emr may not accurately reflect the actual measurement value on the synapse cardiovascular clinical report.
Acción
FujiMedical Systems North America issued intial recall letter dated February 4, 2014, advising users of the HL7 report exported to the EMR wherein measurement values presented in the Hl7 reports in your EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Follow-up letters were issued February 12, 2014, and July 24, 2014. A mandatory upgrade to software version 5.1.1/ base, in-place upgrade required. A customer response form attached to acknowledge receipt and arrange for the on site upgrade. For questions regarding this recall call 203-324-2000.
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
Wire, guide, catheter - Product Code DQX
Causa
Baylis medical company is recalling two lots of protrack microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
Acción
A recall notification, marked "URGENT" will be sent by Baylis Medical via overnight courier to all customers affected by the recall with a fax-back form. The form is to be faxed back to Baylis Medical confirming receipt of the recall notice. As per instructions on the fax-back form, affected devices are requested to be returned. Baylis Medical will replace the returned affacted catheters with a new catheter.
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
Pump, infusion - Product Code FRN
Causa
Medtronic minimed is recalling the minimed 620g and 640g insulin pumps because there are certain scenarios where the set bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
Acción
A customern notification letter sent to customers on 6/19/15 who received the MiniMed 640G insulin pumps. The purpose of the letter is to inform customers that when using Bolus Wizard with the MiniMed 640G insulin pumps, that there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. Customers are informed that Medtronic MiniMed has updated the user guide which instructs to respond promptly to set Bolus screens, and remind not to activate delivery on a bolus based on a blood glucose value that is more than 12 minutes old. The letter informs the customers of the summary of changes in the MiniMed 640G insulin pump user guides.
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
Cleaners, medical devices - Product Code MDZ
Causa
Should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. in addition, it is possible that the ultrasonic generator may stop working. the machine does not provide an alert notifying the user of this device malfunction.
Acción
STERIS sent an Urgent Field Correction Notice letter dated March 9, 2015 customers. The letter identified the description of the product, description of the problem and actions to be taken. For questions contact STERIS Customer Service at 1-800-548-4873 or local sales 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
Staple, implantable - Product Code GDW
Causa
A previous turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. the expiration date at the time of manufacturing was 2014-05.
Acción
Firm is working with EU Rep on English and Turkish notification letters.
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 system is designed to emit a beep upon termination of an exposure. however, if the system has been powered on for over 12 hours, the system will no longer emit this signal. this is a failure to comply with 21cfr 1020.31(j).
Acción
Philips Healthcare Planned action:
1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem.
2. Philips engineers will install the software.
3. Philips engineers will perform testing to ensure the software update was effective.
4. Corrections are to be made free of charge
5. Corrective actions should be completed by August 15, 2015
For further questions call (978) 659-7892
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, stationary - Product Code KPR
Causa
The system is designed to emit a beep upon termination of an exposure. however, if the system has been powered on for over 12 hours, the system will no longer emit this signal. this is a failure to comply with 21cfr 1020.31(j).
Acción
Philips Healthcare Planned action:
1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem.
2. Philips engineers will install the software.
3. Philips engineers will perform testing to ensure the software update was effective.
4. Corrections are to be made free of charge
5. Corrective actions should be completed by August 15, 2015
For further questions call (978) 659-7892
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
The potential exists for the oscillating saw attachment to disengage from the small battery drive handpiece. if the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.
Acción
DePuySynthes sent a "URGENT NOTICE: MEDICAL DEVICE RECALL- CORRECTION" letter dated March 24, 2015 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers review the inventory and perform the in-process inspection outlined in the letter attachment, a review and repair will be implemented if necessary during the next visit schedule maintenance interval at the customer site.
Customers having questions regarding this notice should contact the firm Complaint Handling Unit Manager at 561-494-3673 or to contact their Depuy Synthes Sales Consultant.
For questions regarding this recall call 561-627-1080.
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
An issue was identified with the mas accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Acción
GE Healthcare planned action:
1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX.
2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance.
3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria.
If you have any questions or concerns regarding this notification, please call the
Information following phone number: 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.
Notas adicionales en la data
System, x-ray, mobile - Product Code IZL
Causa
An issue was identified with the mas accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Acción
GE Healthcare planned action:
1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX.
2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance.
3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria.
If you have any questions or concerns regarding this notification, please call the
Information following phone number: 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.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected 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
System, x-ray, mobile - Product Code IZL
Causa
An issue was identified with the mas accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Acción
GE Healthcare planned action:
1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX.
2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance.
3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria.
If you have any questions or concerns regarding this notification, please call the
Information following phone number: 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.
A limited number of vps g4 consoles are being recalled due to noncompliance with international electrotechnical commission standard 60101-1-1.
Acción
Teleflex sent an Urgent Medical Device Recall Notification letters dated on March 30, 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. The risk to users is identified and users are asked to discontinue use and quarantine affected serial numbers. Teleflex sales reps will help with return of product. The Acknowledgeable form should be completed and returned as per instructions. Questions should be directed to 1.877.236.6869.
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,network and communication,physiological monitors - Product Code MSX
Causa
A software defect may cause incorrect medication order change. if the user decides to edit the order prior to electronic signature and selects the return to previous screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. at the stage where the order is signed, the medication displayed may be incorrect.
Acción
Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem.
"Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade.
Please contact your local Philips Representative for further 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.
Notas adicionales en la data
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Causa
The stryker universal battery charger is not transmitting usage data to the stryker cloud as designed. the firm is initiating a software correction to address the issue.
Acción
Stryker issued e-mail notices to distributors and reps on March 26, 2015 advising that all battery charges would receive a software update to provide a field correction for the upgrade to units to be able to track device usage data to Stryker as designed. There is no customer action required, the chargers will transmit a message to Stryker once the upgrade is complete. Please contact Kelly Jo Davis at 269-389-2921 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.
Notas adicionales en la data
Sterilizer, steam - Product Code FLE
Causa
Steris has identified that the control board software in select amsco 400 and amsco c units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. this may result in a procedure delay.
Acción
On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sales 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.
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Acción
The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product to OriGen Biomedical; and complete and return the attached acknowledgement and receipt form even if you do not currently have product in your inventory. The firm recommends that the consignee use an alternate product in the interim.
If you have any questions regarding the return of product that you have on hand or the status of the investigation, please do not hesitate to conact the company at: OriGen Biomedical, Attn: Director, Quality and Regulatory Affairs, 7000 Burleson Rd, Bldg D, Austin, TX 78744 or call +1 512 474 7278 CST Monday-Friday 8:00-5:00.
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
Urinary homocystine (nonquantitative) test system - Product Code LPS
Causa
Deterioration in performance of the liquid stable (ls) 2-part homocysteine reagent resulting in under recovery.
Acción
Axis Shield sent an Urgent Field Safety Notice letter dated March 20, 2015 to their customers via email and written notice sent with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Recommended Action to Customer is as follows: Confirm receipt of FSN to Axis-Shield. Do not use the affected Reagent lots referenced in the safety notice. In the event of holding one of the affected lots, immediately contact Axis-Shield Product Support Department to arrange for replacement material and return any defective product to Axis-Shield. Complete reconciliation form. Complete acknowledgement of the safety notice within 10 working days. Ensure safety notice has been distributed and reviewed by all appropriate personnel within your organization. If further distribution of affected lots to another organization has been made, inform them of this Product Recall and provide a copy of this safety notice to them. Retain a copy of the safety notice for their records.
For any issues or concerns contact Axis-Shield via e-mail; MDL-AXD-Product-
Support@alere.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.
Exactrac 6.X patient positioning system: potentially incorrect patient positioning when using the exactrac cone beam ct (cbct) with a cbct acquired at a couch angle other than 0.0 degrees.
Acción
FIELD SAFETY / PRODUCT NOTIFICATION letters dated March 6, 2015 were sent to all customers of record. The letters included instructions for customers to: 1) With immediate effect, always make sure the couch is at exactly 0.0 degrees (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software; 2) For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0 degrees, Brainlab recommends selecting that option for use in combination with ExacTrac; and, 3) Continue to verify any ExacTrac CBCT based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. The letters further advised that Brainlab will be taking the following actions: 1. Brainlab provides existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian C-Series linac) with this product notification information; and, 2. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customers starting August 2015 to schedule the update installation. Customers with questions about this issue were advised to contact Brainlab at 800-597-5911 or via e-mail by writing at us.support@brainlab.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.
Complaints of difficulties to attach the anatomical shoulder rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). this has the potential for delay in surgery.
Acción
On 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.