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
Facility Use Continuous Ventilator - Product Code CBK
Causa
Patients received insufficient ventilation. the oxylog 3000 instructions are inadequate relating to dead space volume.
Acción
The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales 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
Glucose oxidase, glucose - Product Code CGA
Causa
Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Acción
Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations.
The letter identified the product, the issue, and the actions to be taken by the firm and the customers.
1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility.
2) Replacement will occur in batches of approximately 50 units at a time.
3) Abbott will provide personnel to perform the replacements to help expedite the replacement.
4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..
If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care 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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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 packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. use of a non-sterile product increases risk of patient infection. this recall involes: model 78050 18 gauge pd access vascular access device, model 78060 extended 18 gauge pd access vascular access device, model 75010 18 gauge smartneedle vascular access devices with expiration da.
Acción
Escalon Vascular Access issued an "Urgent: Recall" letter dated May 5, 2010 to customers. The letter identified the affected product being recalled, described the problem, and the actions to be taken.. Consignees were recommended to immediately examine their inventory, quarantine the product, notify their customers, and return product affected. They also advised them that if they have further distributed the product, to please identify the customers and notify them at once of the product recall. Replacement product can be ordered from Vascular Solutions, Inc at 888-240-6001. Customer service can be contacted at 800-676-0043.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Hypodermic Single Lumen Needle - Product Code FMI
Causa
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Acción
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
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
Button, nasal septal - Product Code LFB
Causa
Micromedics, inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
Acción
Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement.
Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Calculator/Data Processing Module For Clinical Use. - Product Code JQP
Causa
Instrument may incorrectly report the result of an antimicrobial sensitivity test.
Acción
The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated August 27, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue associated with the use of GE Centricity Laboratory instrument interface to Biomerieux's Vitek analyzer where results may be incorrectly reported. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.
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
stretcher, wheeled - Product Code FPO
Causa
The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures.
Acción
Stryker Medical sent an Urgent Medical Device Alert letter dated May 15, 2010 to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter stated that there is a possibility for fatigue related failures of certain components of the cot and that a Stryker representative will visit the firm to correct the device.
A representative from Stryker field service would contact the customer to perform the device corrections, free of charge.
Immediate Action required by the customer:
Locate the ambulance cots listed in this notice.
Return the enclosed post card to confirm receipt of this notification.
If any of the cots listed in the letter were loaned or sold the customer was to forward a copy of the notice to the new users and advise Stryker of their new location.
If the customer disposed of any of the affected stretchers and they were no longer in use, customers were to advise Stryker of their obsolescence by providing the serial numbers
For any questions or comments regarding this issue, please call (800) 869-0770, ext. 6902.
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.
Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain boston scientific crt-ds and icds (contak renewal¿ 3 / 3 rf / 4 / 4 rf and vitality¿ he implantable defibrillators). this prevents delivery of programmed tachy therapy, and use of the patient triggered monitor feature. this issue may require.
Acción
Boston Scientific Issued Urgent Medical Device Correction and Physician Device Advisory Notice letters dated July, 2010 to customers identifying the affected devices, the issue prompting the recall, clinical implications, and actions to be taken by customers.
Customers were instructed:
1) Physicians should continue routine follow-up sessions, and patients should be reminded to contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device.
2) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated with a programmer and checked per normal standard of care.
3) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detection of a stuck reed switch. [NOTE 1: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements. NOTE 2: Daily Measurements may be unavailable for reasons other than a stuck switch.]
4) Prophylactic explant is NOT recommended.
5) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures that programmed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off, a magnet will no longer inhibit tachy therapy, and the Patient Triggered Monitor feature will no longer be available.
Do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnet use to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch.
In the US, Boston Scientific Cardiac Rhythm Management can be contacted at 800-227-3422, and in Europe, Boston Scientific Europe S.A. can be contacted at +32 2 416 7222.
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.
Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain boston scientific crt-ds and icds (contak renewal¿ 3 / 3 rf / 4 / 4 rf and vitality¿ he implantable defibrillators). this prevents delivery of programmed tachy therapy, and use of the patient triggered monitor feature. this issue may require.
Acción
Boston Scientific Issued Urgent Medical Device Correction and Physician Device Advisory Notice letters dated July, 2010 to customers identifying the affected devices, the issue prompting the recall, clinical implications, and actions to be taken by customers.
Customers were instructed:
1) Physicians should continue routine follow-up sessions, and patients should be reminded to contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device.
2) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated with a programmer and checked per normal standard of care.
3) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detection of a stuck reed switch. [NOTE 1: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements. NOTE 2: Daily Measurements may be unavailable for reasons other than a stuck switch.]
4) Prophylactic explant is NOT recommended.
5) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures that programmed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off, a magnet will no longer inhibit tachy therapy, and the Patient Triggered Monitor feature will no longer be available.
Do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnet use to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch.
In the US, Boston Scientific Cardiac Rhythm Management can be contacted at 800-227-3422, and in Europe, Boston Scientific Europe S.A. can be contacted at +32 2 416 7222.
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
Lipoprotein-Associated Phospholipase A2 Immunoassay Test System - Product Code NOE
Causa
Product fails stability tests prior to expiration date.
Acción
A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.
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.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
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
Speakers on the philips intellivue x2 and mp2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
Acción
Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks.
Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up.
If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative 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
Detector and alarm, arrhythmia - Product Code DSI
Causa
Speakers on the philips intellivue x2 and mp2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
Acción
Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks.
Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up.
If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative at 1-800-722-9377.