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
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following:
- in artis systems with a100 plus or a100g generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator.
- for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Acción
Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702.
For questions regarding this recall call 610-448-6461.
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
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following:
- in artis systems with a100 plus or a100g generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator.
- for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Acción
Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702.
For questions regarding this recall call 610-448-6461.
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
Clip, implantable - Product Code FZP
Causa
A complaint of the pro2 jaw breaking prior to surgery being performed.
Acción
Recall notification letters were mailed to all Atricure customers. Email notification letters were forwarded to all Atricure field-based personnel, who may also conduct in-person meetings. Telephone calls will be made as needed and effectiveness checks will be conducted.
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
Accelerator, linear, medical - Product Code IYE
Causa
Modifications in version 13.6mr2 for contouring, smartadapt, and smartsegmentation workspaces resulted in contours not being saved consistently in eclipse. treatment planning system. the issue only occurs if certain conditions are fulfilled.
Acción
Varian Medical Systems sent an Urgent Medical Device Correction Letter dated December 5, 2016 , that were sent to all 5 affected sites on December 5, 2016 by a trackable method.
Letters advised users of the issue and the specific scenario that must take place for the issue to occur. Varian is investigating the issue and will provide a correction once it is available.
We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions please call (650) 424-6833.
Varian Oncology Help Desk Contact Information:
Phone: +1.888.827.4265
Email: support @varian.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.
Products were made outside of quality system regulation, and potentially outside of premarket submission (510k/pma) for certain devices.
the safety or effectiveness of these devices cannot be assured.
Acción
DePuy Synthes sent an URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS dated January 6, 2017, to all affected customers. .
Customerss were instructed to identify all medical facilities that may have used or received the affected instruments and identify the modified instruments used at each facility. This information was to be used to generate Reconciliation Forms for each impacted Medical Facility. The Reconciliation Forms and URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS recall notifications were then delivered by DePuy Synthes Sales Consultants to the affected medical facilities.
Instructions in the URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS provided to the medical facilities included the following:
Please take the following actions:
" Please immediately cease using the modified instruments identified in the attached Reconciliation Form. Your U.S. DePuy Synthes Sales consultant will work with your facility to locate and replace any affected instruments.
" If your facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon, and it is not listed on the attached Reconciliation Form, please contact your DePuy Synthes Sales Consultant for an evaluation to determine if the instrument should be returned and replaced.
WI-9956 | Rev 5 | Attachment B2
" Return Affected Instruments:
o Medical facilities are to determine if any of the recalled instruments are still on hand by working with your U.S. DePuy Synthes Sales Consultant, and return affected devices immediately to their U.S. DePuy Synthes Sales Consultant or return them to DePuy Orthopaedics, Inc. for credit following normal purchasing procedures.
o Note: These instruments may be on consignment at your facility.
" Reconciliation Form: Complete the Reconciliation Form and return to your U.S. DePuy Synthes Sales Consultant or
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
Multiple issues have caused the device to result in ct rescans or incorrect scan location or misrepresentation of image results.
Acción
Philips sent a Customer Information Letter dated December 13, 2016 to customers via certified mail. The letter identified the affected product, problem and actions to be taken. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).
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
Reagent, general purpose - Product Code PPM
Causa
A drift of the performance with the bk test (bk virus, worst case application) was observed for some silica batches of magnetic silica (magsil). this is the same issue as in recall z-2342-2016.
Acción
Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
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
Reagent, general purpose - Product Code PPM
Causa
A drift of the performance with the bk test (bk virus, worst case application) was observed for some silica batches of magnetic silica (magsil). this is the same issue as in recall z-2342-2016.
Acción
Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
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.
Incorrect enhanced dynamic wedge (edw) or virtual wedge (vw) calculations.
Acción
Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice included a reply form to be returned to Elekta.
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
Screw, fixation, bone - Product Code HWC
Causa
Four lots of tiger screw sterilization tray base assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Acción
Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.
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
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Causa
Ge healthcare surgery announces a voluntary field action for the oec miniview 6800, oec 9900 elite, and oec 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Acción
GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
For questions regarding this recall call 801-536-4952.
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, Medacta International, immediately notified all customers by phone on 12/07/16 and further notified via email on 12/9/16. The firm also issued an "URGENT- Field Safety Notice" dated 7/12/2016 to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to return all units to Medacta International SA and forward the notice to all people and organizations potentially affected.
If you have any questions contact Regulatory Affairs Manager at +41 (0) 91 696 60 60.
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
When the uf rate, goal or time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled uf rate is actually being executed rather than rate displayed on the machine.
Acción
Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM.
Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
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
When the uf rate, goal or time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled uf rate is actually being executed rather than rate displayed on the machine.
Acción
Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM.
Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
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
When the uf rate, goal or time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled uf rate is actually being executed rather than rate displayed on the machine.
Acción
Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM.
Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
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, radiation therapy, charged-particle, medical - Product Code LHN
Causa
An error can occur causing delta corrections to be lost when one setup field is closed and another is opened.
Acción
Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
When the uf rate, goal or time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled uf rate is actually being executed rather than rate displayed on the machine.
Acción
Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM.
Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
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
Syringe, restorative and impression material - Product Code EID
Causa
Ultradent products, inc. announces a voluntary field action for the nanotips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
Acción
Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.
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
Counter, differential cell - Product Code GKZ
Causa
Beckman coulter has determined that additional clarification for the blast suspect messages is necessary. in rare situations, the unicel dxh 800 and dxh 600 coulter cellular analysis system may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as sample limitations.
Acción
Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the United States and Canada, and outside the United States and Canada, to contact their local Beckman Coulter 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
Counter, differential cell - Product Code GKZ
Causa
Beckman coulter has determined that additional clarification for the blast suspect messages is necessary. in rare situations, the unicel dxh 800 and dxh 600 coulter cellular analysis system may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as sample limitations.
Acción
Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the United States and Canada, and outside the United States and Canada, to contact their local Beckman Coulter 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
System, communication, powered - Product Code ILQ
Causa
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
Acción
Stanley Healthcare sent an Important Recall Notice dated June 22, 2016, to all affected customers. The notice instructed customers to discontinue use of the device and to contact the recalling firm to arrange for return of the device. The recalling firm also asked the customer to complete a response form indicating they read, understood and complied with the recall notice. Customers with questions were instructed to contact Arial Customer Service at 888-716-0077. For questions regarding this recall call 781-216-9035.
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
Lambda, antigen, antiserum, control - Product Code DEH
Causa
Batch numbers listed are reporting lambda free light chain results >114mg/l that are on average 33% lower than other optilite lambda freelite batches. therefore users moving to this batch will see results >114mg/l giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
Acción
On 07/05/16 notification letters were sent to customers.
The Binding Site Group requests the following:
- Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock;
- Remove any affected lots from the Optilite instrument;
- Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable;
- Notify local Binding Site representative to request replacement kits;
- Return completed E-Back Form to local Binding Site Representative;
The firm recommended that the notice be circulated to those within the organization who need to be aware.
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
Lambda, antigen, antiserum, control - Product Code DEH
Causa
Calibration curve activity has increased over time in the kit lots listed.
Acción
Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Beckman coulter initiated a design change to update the automate pc image to accommodate the operating system change to windows 10.
Acción
The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification.
If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: RegulatoryAgencyInquiries@beckman.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
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Acción
Hitachi sent an Urgent : Device Correction Notice dated January 3, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The firm plans to visit each site and replace the cable balun and also confirm receipt of the notification letter. The firm will quarantine returned baluns in their warehouse until they are reworked. For further questions regarding this recall please call (330) 425-1313 ext. 3720.