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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Increased u90-382 or 6lu condition codes generated by vitros 250, 350, 5,1 fs, 4600 and 5600 chemistry systems when using calibrator kit 9, lot 954. a trend of complaints regarding customers actions following u90-382 or 6lu condition codes was noted (see res 72289 - vitros calibrator kit 9, lot 954 recall).
Acción
Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
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
Increased u90-382 or 6lu condition codes generated by vitros 250, 350, 5,1 fs, 4600 and 5600 chemistry systems when using calibrator kit 9, lot 954. a trend of complaints regarding customers actions following u90-382 or 6lu condition codes was noted (see res 72289 - vitros calibrator kit 9, lot 954 recall).
Acción
Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
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
Increased u90-382 or 6lu condition codes generated by vitros 250, 350, 5,1 fs, 4600 and 5600 chemistry systems when using calibrator kit 9, lot 954. a trend of complaints regarding customers actions following u90-382 or 6lu condition codes was noted (see res 72289 - vitros calibrator kit 9, lot 954 recall).
Acción
Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
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
Endoscope, flexible - Product Code GCQ
Causa
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Acción
The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
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
Increased u90-382 or 6lu condition codes generated by vitros 250, 350, 5,1 fs, 4600 and 5600 chemistry systems when using calibrator kit 9, lot 954. a trend of complaints regarding customers actions following u90-382 or 6lu condition codes was noted (see res 72289 - vitros calibrator kit 9, lot 954 recall).
Acción
Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Endoscope, flexible - Product Code GCQ
Causa
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Acción
The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Resmed corporation is recalling astral 100, 150 external battery because of a start-up issue.
Acción
ResMed sent an Urgent Safety Alert dated January 13, 2016, to all affected customers. The Alert identified the product, the problem, and the action to be taken by the customer.
The notification letter provided the following instructions to distributors
Field devices can be upgraded using ResMed Service Software or at an authorized ResMed Service Center. Contact Astral Support for further details.
The SR2 software update will be available free of charge and should be implemented for all devices within the two-year service cycle or before at the customers preference.
To acknowledge receipt of this Astral Safety Alert, submit this form.
For any questions call Astral Support:
855-245-4640
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, estradiol - Product Code CHP
Causa
The drug fulvestrant (faslodex¿) may cause falsely elevated estradiol results.
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016.
The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support 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
Radioimmunoassay, estradiol - Product Code CHP
Causa
The drug fulvestrant (faslodex¿) may cause falsely elevated estradiol results.
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016.
The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support 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
Radioimmunoassay, estradiol - Product Code CHP
Causa
The drug fulvestrant (faslodex¿) may cause falsely elevated estradiol results.
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016.
The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support 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
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Causa
On the label calcium (ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 meq/l ca. the concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 meq/l.
Acción
The firm, Fresenius Medical Care, issued an "URGENT-MEDICAL DEVICE RECALL" letter dated 1/14/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your stock for the product; if found, discontinue use immediately; place all units in a secure, segregated area; contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions how to return the affected lot (lot# 15STAC072), and promptly complete and return the attached reply form by Fax to: 781-699-9796 Attn: Quality Department or scan and email to: NOTIFYRA@fmc-na.com. Fresenius will pick up and replace your product.
If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-816-2309 or Website: www.fresenius-medinfo.com.
Further information or support concerning this issue, contact the Customer Service Care Team at 800-323-5188 and reference the and Support Field Action Number.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Punch, surgical - Product Code LRY
Causa
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. this may cause the surgeon to select an insert that is too thin. surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. insert dislocation or spin out, or poor joint mechanics may result, if not noted during surgery. may require revision surgery.
Acción
On 1/8/2016, URGENT INFORMATION RECALL NOTICE for Specific Lots of SIGMA¿ High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying 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.
For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. 5 p.m. EDT).
For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).
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.
Siemens healthcare diagnostics has confirmed an increase in the rate of abnormal assay errors and calibration failures with the dimension vista b2mic flex reagent cartridge: dimension vista system flex reagent cartridge and urine stabilizer b2mic. in the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.
Acción
Siemens sent an Urgent Medical Device Recall dated November 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and discard your remaining inventory of the affected product. Indicate your replacement product needs on the attached Field Correction Effectiveness Check Form and return. For questions call Siemens Customer Care Center- Technical Solutions at 800-441-9250 or your local Siemens technical support 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
Endoscope, flexible - Product Code GCQ
Causa
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Acción
The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
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
Needle, tumor localization - Product Code MIJ
Causa
Product potentially exposed to body fluids during processing. potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. however, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
Acción
Cook Medical sent an URGENT: MEDICAL DEVICE RECALL dated January 8, 2016, to all affected customers via courier with instructions for identifying 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. Customers were instructed to do the following:
Please review the attached list of affected products and lot numbers shipped to your account, and quarantine any affected
product that remains unused.
2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit.
3. Please complete the attached Recall Response Form and return to Cook Medical either with the product or separately.
4. Please report any Adverse Event to Cook Medical Customer Relations 1-800- 457-4500 or 1-812-339-2235. Monday
through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or email at FieldActionsNA@Cookmedical.com
Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
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
Accessories,arthroscopic - Product Code NBH
Causa
Blade exhibiting fracture during hip arthroscopy procedures.
Acción
Smith & Nephew issued letters via Federal Express on January 11, 2016. requested to inspect inventory and locate any unused devices and quarantine them immediately.
Complete Inventory Return Certification Form on the following page, indicating the quantities that need to be returned.
Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
The system loaded a completion fraction in the incorrect order after a treatment interruption.
Acción
ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan.
While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan.
If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay" Customer Support center at 855-286-
8875.
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 discovered four issues with the brightview family systems.
issue 1:
during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan.
issue 2:
during a scan, the gantry motion may halt prematurely. this cause.
Acción
On 12/22/2015, the firm sent Customer Information Letters to their consignees.
The letter identified the product, problem and actions to be taken by the 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.
The firm discovered four issues with the brightview family systems.
issue 1:
during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan.
issue 2:
during a scan, the gantry motion may halt prematurely. this cause.
Acción
On 12/22/2015, the firm sent Customer Information Letters to their consignees.
The letter identified the product, problem and actions to be taken by the customers.