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
Fluoroscopic X-ray system - Product Code MQB
Causa
Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems.
the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
Acción
The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
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
Fluoroscopic X-ray system - Product Code MQB
Causa
Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems.
the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
Acción
The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
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
Fluoroscopic X-ray system - Product Code MQB
Causa
Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems.
the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
Acción
The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
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
Fluoroscopic X-ray system - Product Code MQB
Causa
Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems.
the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
Acción
The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
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
Fluoroscopic X-ray system - Product Code MQB
Causa
Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems.
the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
Acción
The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.
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
Causa
Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the fda.
Acción
Nebion LLC contacted each holder of a device by telephone on July 2, 2008, and then mailed the recall letter titled URGENT MEDICAL DEVICE RECALL FOR NEBION HLX-8 by with attached recall response form. The customers were requested to completed the questionnaire (recall response form) and mail or fax it back to the company.
The Letter instructed customers to stop using the device immediately and contact Nebion to have the device picked up at Nebion's expense by UPS. They were also instructed to report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax (information given regarding the FDA's MedWatch program).
If you have questions, contact David LaPoint at 714-614-3141.
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
Arrhythmia Detector and alarm - Product Code DSI
Causa
Potential for module to fail to obtain a nibp reading on hypertension patients.
Acción
On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.
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
Indicator, physical/chemical sterilization process - Product Code JOJ
Causa
The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.
Acción
On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).
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
Biliary Catheter - Product Code FGE
Causa
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
Acción
Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.
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
Biliary Catheter - Product Code FGE
Causa
It is possible the stents inside clso-10-10, lot w2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label.
Acción
Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.
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
Applier, Hemostatic Clip - Product Code HBT
Causa
Hole in the sterile unit blister pack that could compromise sterility.
Acción
The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the 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
Arrhythmia Detector and Alarm - Product Code DSI
Causa
During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
Acción
On 07/17/08 the firm issued a "URGENT - MEDICAL DEVICE CORRECTION" letter to their customers who received the Spacelabs Medical 1400 MHz Telemetry System - Model 91341-09. The letter states the circumstances in which the device malfunctions, instructions for staff to confirm at the time of the battery insertion that the data is appearing and to remove it from service if information is not appearing. Letters will be sent with a return receipt acknowledging each customer receives the Medical Device Correction letter. Spacelabs Technical Support will respond to all technical questions and personally upgrade all switches with resisters. Contact Spacelabs Medical at 1-800-522-7025 for assistance.
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.
Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
Acción
Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.
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
Defibrillator - Product Code MKJ
Causa
Defective internal memory cards may exhibit one or more of the following behaviors:
"device repeatedly restarts approximately every 20 seconds
"slow device start-up of approximately 15 seconds or more. during this time, the mrx displays either a blank screen or the philips heartstart mrx start-up screen prior to displaying the selected mode of operation (i.E. monitor, aed, pacing or manual defib mode).
" internal memory failure inop message when attempting to print an event from the data management screen.
"when printing from the data management screen, a patients event summary prints with some clinical events missing.
Acción
Philips issued an Urgent Medical Device Correction notification on July 17, 2008. Customers in the US received their communication package via UPS. Letters to international
customers mailed via a tracked method by local Philips representatives. Customers were informed on how to locate the serial number on their devices to determine whether or not they have affected units in their inventory. Customers are asked to follow the "Action To Be Taken By Customer/User" while they await , their correction. If users continue to use prior to correction, a back up defibrillator should be readily available. Devices that exhibit repeated restart or slow start -up should be removed from service. The correction will come in the form of an internal memory card replacement.
Philips will contact customers to arrange for the correction of their devices. Contact Philips Medical at 1-978-687-1501 for assistance.
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
Invasive Traction Component - Product Code JEC
Causa
Parts are non-functional. the user is unable to fully pass the fixator pins through the body of the stableloc assembly as required. the kit may also be missing the set screw.
Acción
The firm sent "Urgent Field Safety Notice: Medical Device Recall" letters to customers 7/9-11/08. In addition, the firm sent the letter via e-mail to some of the customers. The notification advised the customer of the recall, identified the product, explained the reason, and asked the customer to locate and segregate any affected product. The customer was asked to notify their customers who they had distributed the affected product to and asked them to complete and return an enclosed response form. The firm provided a model recall letter for its agents/distributors to issue to users. Upon receipt of the response form, the firm will contact customers to arrange for replacement of any affected product. Questions should be directed to the "Distributor phone number" or Richard Snyder, Quality Manager at 1-888-627-9957.
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 Gas machine - Product Code BSZ
Causa
The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
Acción
The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
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
Vestibular analysis apparatus - Product Code LXV
Causa
The firm distributed an unapproved medical device.
Acción
On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.
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
Automated Slide Stainer - Product Code KPA
Causa
Beckman coulter has become aware of a potential issue in which the sample id information embedded in the barcode affixed to a slide made by the coulter gen*s and lh slidemaker does not match the text.
Acción
An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to:
1. Only use upper case alpha characters in the Sample Identifier
2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code.
Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.
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 - Product Code CBK
Causa
Certain plv-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.
Acción
The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance.
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
Automated Slide Stainer - Product Code KPA
Causa
Beckman coulter has become aware of a potential issue in which the sample id information embedded in the barcode affixed to a slide made by the coulter gen*s and lh slidemaker does not match the text.
Acción
An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to:
1. Only use upper case alpha characters in the Sample Identifier
2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code.
Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.
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
Telemetry Reciever - Product Code DSI
Causa
Telemetry modules are failing to alarm for low heart rate and asystole.
Acción
On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.
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
Picture Archiving and Communication System - Product Code LLZ
Causa
Scout line and localizer crosshair on mpr images will display in the incorrect position under certain circumstances.
Acción
A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.
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.
Some products may contain the incorrect introducer stylet. if the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. other risks include delay to surgery and inconvenience to patient.
Acción
Recall initiated on June 23, 2008. A recall letter and reconciliation form was sent out via e-mail to sales representatives for hand delivery to US hospital consignees. The consignees were asked to review the letter and complete/return the reconciliation form to the firm. If you have any questions contact Kyphon, Inc. at 1-408-548-6740.
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
hip metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis - Product Code LZO
Causa
When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
Acción
The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.
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
hip metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis - Product Code LZO
Causa
When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
Acción
The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.