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 health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the vertier surgical table.
Acción
An "URGENT: Device Recall" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.
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
Detector and alarm, arrhythmia - Product Code DSI
Causa
Ge healthcare has become aware of a potential issue associated with the failure to restart carescape cic pro v5.1 on the mp100 hardware. this issue may impact patient safety.
Acción
A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by
GE Field Service team members.
For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pin, fixation, smooth - Product Code HTY
Causa
The package contains pins with an incorrect diameter.
Acción
Zimmer, Inc. issued an "Urgent: Device Recall" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265.
For further questions, contact Zimmer, Inc. at 1-800-613-6131.
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
Medical computers and software - Product Code LNX
Causa
Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
Acción
Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.
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
Activated whole blood clotting time - Product Code JBP
Causa
One lot of act-lr was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
Acción
An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases.
If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at JACTLR@itcmed.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, network and communication, physiological monitors - Product Code MSX
Causa
Ge healthcare has recently become aware of an issue in the calculations associated with datex-ohmeda s/5 device interfacing solution n-disvent-02 interfaced between certain datex-ohmeda patient monitors (datex-ohmeda s/5 anesthesia monitor (am), datex-ohmeda s/5 critical care monitor (ccm), datex-ohmeda s/5 compact anesthesia monitor (cam), datex-ohmeda s/5 compact critical care monitor (cccm)) an.
Acción
An "Urgent Medical Device Correction" letter was issued to consignees on or about April 9, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A representative from GE Healthcare will contact customers to schedule implementation of the correction when it is available for installation at the customer's facility.
Direct questions regarding this notice to GE Healthcare Technical Support or your local GE Distributor and refer to FMI 36042.
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
Ge healthcare has recently become aware of the need to adjust default settings associated with the use of ct perfusion 4 on the advantage workstation, st and pet/ct consoles that may impact patient safety.
the default parameter settings in ct perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (isd) greater th.
Acción
GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 23, 2009. The letter was addressed to Hospital Administrators / Risk managers and Radiology department mangers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information instructing the user to follow the enclosed User Guide Addendum to mitigate further problems.
For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan); for other countries, contact your local GE Healthcare field service representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
Acción
Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, monitoring, perinatal - Product Code HGM
Causa
Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions.
Acción
Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade.
Questions can be made to Philips response center at 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
System, monitoring, perinatal - Product Code HGM
Causa
Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions.
Acción
Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade.
Questions can be made to Philips response center at 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.
The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece.
Acción
An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.
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
air therapy mattress - Product Code IOQ
Causa
The devices may emit smoke from the blower box assembly.
Acción
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
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
air therapy mattress - Product Code IOQ
Causa
The devices may emit smoke from the blower box assembly.
Acción
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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
Surgeon's gloves - Product Code KGO
Causa
Premature degradation which could result in tearing during use.
Acción
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC 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, nuclear magnetic resonance imaging - Product Code LNH
Causa
Combined use of the synergy flex-m / shoulder coil 1.5t increases the chance of rf interaction and heating up of the coil. this may result in possible burns of the patient.
Acción
Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil.
Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.