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 were received which described the synfix lr implant holder breaking at the interface between the implant and the holder.
Acción
Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to:
Credit/Returns
Synthes
1101 Synthes Avenue
Monument, CO 80132
Customers were also instructed to return the Verification Section even if they don't have the affected product.
Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant.
For questions regarding this recall call 610-719-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Washer, bolt nut - Product Code HTN
Causa
During a retrospective assessment, spiked washers 13.5/6.5 were discovered to be mislabeled as spiked washers 13.5/5.5.
Acción
SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to:
Credit/Returns
Synthes
1101 Synthes Avenue,
Monument, CO 80132
Customers were also asked to return the Verification Form indicating they did not have the affected product also. All documents were to be returned to Synthes by:
Fax 1-877-270-5855
Scan/email: FieldAction@synthes.com
Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant
For questions regarding this recall call 610-719-5000..
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Nail, fixation, bone - Product Code JDS
Causa
Complaints were received reporting that a product packaged as a 14.5 mm outer protection sleeve for suprapatellar contained a 12.0 mm outer protection sleeve for suprapatellar.
Acción
Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to:
Credit/Returns
Synthes
1101 Synthes Avenue
Monument, CO 80132
If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by:
Fax: 866-229-7778
Scan/email: FieldAction@synthes.com
Customers with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Acción
Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688.
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 labeling correction was initiated related to the surgical technique guide j5606-c "tomofix osteotomy system" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
Acción
Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter dated October 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to exchange the old surgical technique guide version J5606-C with the new version J5606-D provided with this notification.
Review the revised surgical technique guide (Pages 25 & 26).
Forward this Field Safety Notification to anyone in their facility that need to be informed.
If the surgical technique guide has been forwarded to another facility, contact that facility.
Maintain awareness of this notice until all surgical technique guides have been exchanged.
Maintain a copy of this notice.
Customers with questions were instructed to contact their Synthes
Sales Consultant. For questions regarding this recall call 610-719-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
When utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system, and then use the incorrect flex cartridge to process the user defined method.
Acción
Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring:
1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide.
2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing.
3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director.
We apologize for the inconvenience this situation has caused. If you have any questions, please contact your 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
Introducer, catheter - Product Code DYB
Causa
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
Acción
Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product.
Customers with questions were instructed to contact their local sales representative or Customer Service at 1-800-343-2935.
For questions regarding this recall call 610-378-0131.
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
Anesthesia conduction kit - Product Code CAZ
Causa
A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
Acción
The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
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
Pack, hot or cold, water circulating - Product Code ILO
Causa
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. 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.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Acción
Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batches of coolpath duo ablation catheter mediguide enabled products and safire duo ablation catheter mediguide enabled. these units were inadvertently shipped with the incorrect version of the instructions for use (ifu).
Acción
The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
If you have any questions, contact Vice President, Quality, at 651-756-5402.
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 hand piece high deployment force exceeded the maximum specification.
Acción
Consignees were sent a Urologix Urgent Medical Device Recall letter dated October 21, 2013. The letter described the problem and the device involved in the recall. Advised consignees to examine their inventory and remove the recalled product. Requested consignees to complete and fax the "Customer Acknowledgement Form" to Hope Przybilla at 763-475-1443 or call her for questions. The consignees local representatives will be personally assisting them with the return process and ensuring that replacement product is offered and received promptly.
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
Radiation Therapy Treament Planning System - Product Code MUJ
Causa
Ray search laboratories found an issue with the dose calculation for elekta motorized wedges in ray station 3.0, 3.5 and 4.0. the error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Acción
Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
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
If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
Acción
Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.
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.
Microgenics corp., part of thermo fisher scientific, is recalling cedia tobramycin ii assay (lot number: 60169764) due to calibration stability problem relating to two complaints received.
Acción
Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact mgc@thermofisher.com. For question regarding this recall call 1-800-232-3342.
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.
An error was identified in the real time controller (rtc) firmware versions 3.0, 3.1, 3.2, and 3.3 used in vantage panoramic x-ray systems. the error may cause the column of the vantage panoramic x-ray unit to continue moving vertically despite the release of the movement control button (i.E. failure to stop").
Acción
An URGENT MEDICAL DEVICE FIELD CORRECTION letter dated September 20, 2013 was sent to all consignees.
Letters sent to distributors include instructions on how to identify the defective units, to quarantine the machine(s), and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will either schedule an on-site field correction or arrange for the replacement of the affected device(s) depending on the customer's preference. Midmark further requested the distributors provide Midmark with the names, addresses, phone numbers, and e-mail addresses of any customers that purchased any defective units.
Field corrections include the upgrading of RTC firmware to revision 3.4 on the defective units and will be performed as no additional charge by Midmark personnel.
Letter sent to practitioners include instructions on how to identify the defective units, instructions on how to temporarily reduce the likelihood of the unintentional movement, and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will schedule an on-site field correction by upgrading the firmware to revision 3.4.
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, test, blood glucose, over the counter - Product Code NBW
Causa
There is a software synchronization issue with the accu-chek combo system. in rare cases, when the manual pump option is chosen on the accu-chek aviva combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
Acción
The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option.
Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578.
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
Peritoneal system automatic delivery - Product Code FKX
Causa
In systems with version 10.4 software initial drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). the operator can stop, but cannot bypass, the active initial drain. this is to mitigate against unintended increased intraperitoneal volume (iivp). this can cause serious problems in patients with unrelated a co-morbid condition of ascites.
Acción
An IMPORTANT PRODUCT INFORMATION letter dated October 7, 2013, was sent to all affected customers.
The letter included instructions for clinicians to: 1) be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial Drain); 2) review HomeChoice instructions for use for additional details on HomeChoice 10.4 Initial Drain Logic; 3) acknowledge your receipt of the notification by completing the attached Customer Reply Form and returning by fax to either 224-270-5457 or scanning and e-mailing it to fca@baxter.com; 3) if the recipient of the letter is a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, to forward the communication to all customers who may have received these products.
Clinical questions should be addressed to Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00PM CST). General questions about this recall should be addressed to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).
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
Component, external, limb, ankle/foot - Product Code ISH
Causa
Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Acción
Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer.
¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action:
" Please identify the users of each of the A-642100 adapters, see attached list.
" Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users.
A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer.
For further questions please call (949) 360-3634.
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
Applied medical is conducting a voluntary recall of the inzii¿ 12/15mm retrieval system. during shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmen.
Acción
Customer notifications of the recall began the week of 10/21/2013 via UPS overnight with letters requesting that all affected products be returned to Applied. The notification letter is dated October 21, 2013 and titled "URGENT: MEDICAL DEVICE RECALL". The notification was accompanied by a Recall Notification Confirmation Form. The letter informed customers of the recall by providing the product description with codes (Model and Lot Numbers). reason for the recall, actions to take and contact information.
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 an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Acción
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
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 an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Acción
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
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 an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Acción
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
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 an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Acción
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Ge healthcare has recently become aware of a potential safety issue related to a spect scan procedure used for pulmonary imaging.
contact between the detector (ge healthcare discovery nm/ct 670, and/or optima nm/ct 640, and/or discovery
nm630, and/or brivo nm 615 all configurations) and the patient's elbow may occur during spect protocols using 450 angular steps in scenarios when a patients a.
Acción
GE Healthcare sent an "Urgent Medical Device Correction" letter dated September 25, 2013, to all affected customers. The letter identified the product the problem and the actions to be taken by the customer.
We plan to correct all of the affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 systems that were distributed
The plan for public warning is to contact all customers with an affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 system by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to 3 titles within the affected accounts; Managers of Nuclear Medicine, Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology. A GE Healthcare Field Engineer will perform the required software update on each affected system.
Contact Information (GE Healthcare Call Center: USA or Canada 800-437-1171 and Other countries:( 262-896-2890).