"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Non-compliant and inaccurate (up to 0.5°c) aid fast, 1st aid and powerplast digital thermometers have been provided to discount outlets in ireland. these digital thermometers are not appropriately ce marked. these thermometers may be marketed under a variety of brands and the packaging may vary.
Acción
Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices branded Aid Fast, 1st Aid or Powerplast digital thermometers. If you find that you have these products cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance. Also, should you discover any other similar brands of digital thermometers that do not clearly identify the manufacturers name and address on the packaging, please advise the IMB. Advice for Consumers Consumers should check their digital thermometer to determine if their device is branded Aid Fast, 1st Aid or Powerplast. If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Non-compliant ‘first steps’ medicine feeders have been provided to retail outlets in ireland by rsw international limited. these medicine feeders are not appropriately ce marked.
Acción
Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range.
If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.
Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB. Advice for Consumers
Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range.
If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
Acción
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Contoura 880 beds.
3) Determine if your institution has devices affected by this issue.
This can be determined by:
A) Checking the manufacturing date to see if it is between December 1999 and June 2001.
B) Checking if the Serial number lies in the range 167386 to 382938.
4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.
5) Ensure that correction is completed on all affected devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The optium xceed blood glucose meter (manufactured by abbott diabetes care) or boots brand blood glucose meters, may generate incorrect results when used in conjunction with the onetouch ultra test strips, manufactured by lifescan.
Acción
The IMB recommends that users follow the manufacturer’s instructions for use and User’s Guide to determine which blood glucose meters and test strips are compatible.
Table showing compatible meters and test strips Manufacturer Meter Compatible test strip Abbott Diabetes Care Optium Xceed Optium Plus test strips
(foil wrapped) Boots Boots Brand Optium Plus test strips
(foil wrapped) LifeScan OneTouch Ultra
OneTouch Ultra 2
OneTouch UltraEasy
OneTouch UltraSmart OneTouch Ultra test strips Pharmacists supplying OneTouch Ultra test strips and Optium Xceed or Boots brand meters: If you supply Optium Xceed or Boots brand meters you should advise the user to only use Optium Plus test strips. When you dispense OneTouch Ultra test strips you should advise the user that these test strips are only intended for use with the OneTouch Ultra brand meters. GPs prescribing blood glucose meter test strips: Only prescribe Optium Plus test strips for use with Optium Xceed or Boots brand meters. Only prescribe OneTouch Ultra test strips for use with OneTouch Ultra brand meters. Healthcare professionals managing patients who use the affected devices: Advise patients to ensure that they are using the correct test strips for their meter as described in the meter’s user manual.
Healthcare professionals who use these devices: Ensure that Optium Plus test strips are only used with the Optium Xceed or Boots brand meters. Ensure that OneTouch Ultra test strips are only used with the OneTouch Ultra brand meters. General public: Only use Optium Plus test strips with the Optium Xceed or Boots brand meters. Only use OneTouch Ultra test strips with OneTouch Ultra brand meters. Please bring this safety notice to the attention of all who need to be aware of it. This will include further distribution to:
Accident & Emergency Departments
All wards
Ambulance services directors
Ambulance staff
Biochemists
Chief pharmacists
Clinical pathologists
Clinical pathology directors
Day surgery units
Diabetes clinics / outpatients
Diabetes nurse specialists
Hospital pharmacists
Medical Directors
Nursing executive directors
Outpatient clinics
Outpatient theatre managers
Outpatients theatre nurses
Pharmacists
Point of care testing co-ordinators
Risk managers
The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the website.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The zoll aed plus defibrillator may not deliver therapy.
Acción
1. Ensure that the relevant personnel in your organisation are made aware of this issue.
2. Determine if you have purchased the affected serial numbers of this product, AED Plus devices with serial numbers below X_ _ _200000.
3. If you have an affected device confirm that the recommended actions have been completed:
Ensure that the date when the batteries were installed in your device has been checked.
a. If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the label provided by Zoll showing the next scheduled replacement date. Read and add the addendum incorporating this information to the administrator’s guide that was provided by Zoll.
b. If batteries are not more than three (3) years old, add the label provided by Zoll completed with the next scheduled replacement date. Read and add the addendum, provided by Zoll, incorporating this information to the administrator’s guide.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
Acción
Advice for Retailers and Wholesalers
(1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.
(2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.
(3) Ensure the appropriate personnel are made aware of this notice. Advice for Healthcare Institutions / Consumers
(1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.
(2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.
(3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.
(4) Ensure the appropriate personnel are made aware of this notice.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
A manufacturing problem has been detected where under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimum temperature delivery to the treatment site.
Acción
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Wallach LL100 Cryosurgical System CO2 and Accessories.
3) Follow the instructions outlined in the attached FSN from Wallach Surgical regarding this action.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Abbott has determined that s/co values generated with architect anti-hcv (ln 6c37) may decrease when 25% or less of test volume is remaining leading to:
• abbott positive control values shift down and/or out of range low, • non-abbott positive control values shift down and/or out of range low, and/or • a decrease in patient result values.
Acción
Abbott has issued a Field Safety Notice (FSN) (March 2010) to all Irish customers using the ARCHITECT Anti-HCV assay recommending customers mix the ARCHITECT Anti-HCV assay diluent (LN 6C37J, green bottle label) prior to testing each day of use.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Certain philips respironics humidifiers may present a risk of potential burn if handled while exhibiting thermal deformation due to a connector failure. this is due to an intermittent connection between the heater plate and the printed circuit board which results in a blinking led on the humidifier control knob.
Acción
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Philips Respironics M Series Heated Humidifiers.
3) Determine if your institution has devices affected by this issue (check the serial numbers).
4) Examine the humidifier control knob for a blinking blue light as shown in the attached field safety notice issued by the manufacturer.
5) Ensure that corrective action is completed on all affected devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.
Acción
• Ensure the appropriate personnel are made aware of this notice.
• Ensure that the patient follow up recommended by the manufacturer is followed (please see above).
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The potential supply and use of a counterfeit haemorrhoidal circular stapler product called proximate® pph procedure for prolapse and hemorrhoids set, product code pph03, from the above batch that is not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
Acción
The IMB advises that:
All product in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.
• If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local EES representative, JOhnson Ireland, who will be able to confirm if the product is authentic.
• If you identify that you have product that is counterfeit you should return any such affected product in your possession to
Johnson & Johnson Ireland, and inform the IMB.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The potential for the lifepak® cr plus to not deliver therapy still exists due to a device upgrade that has not been completed on all of the affected devices on the irish market.
Acción
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify affected LIFEPAK® CR Plus defibrillators (Please see Attachment 1 for affected serial numbers)
3. Confirm if defibrillators have been upgraded by Oxygen Care (repair and servicing company for Physio-Control products in Ireland) in relation to this issue.
4. If any of the affected defibrillators has not been upgraded, immediately contact Medtronic or Oxygen Care (see contact details below) to arrange the correction of the defibrillator, and follow the recommendations listed in the FSN.
5. Perform regular monthly inspection as per LIFEPAK® CR Plus operating instructions AND verify that the voice prompt is heard at power on.
6. If, at any time, the voice prompt is not heard or any other indicator displays bar “OK”, immediately contact Medtronic.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Recall of depuy’s asr™ hip implant system due to higher than expected revision rate.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Stryker has become aware that the head end slide tube, bushings and head end release rod of the model 6100 m1 ambulance cot can break during use, potentially resulting in the head end of the cot collapsing.
Acción
As there are no sales records, the IMB are requesting that healthcare workers contact Stryker UK if they are aware that this device has been distributed in Ireland.
If affected devices are located at your facility and the unit does not operate properly, remove the unit from service and contact Stryker UK to arrange for a device retrofit / upgrade. The attached field safety notice issued by Stryker provides further information on this issue.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
A recall of silicone gel filled breast implants manufactured by the french company poly implant prothese (pip) was initiated in ireland on the 30th march 2010. the recall follows a manufacturing site inspection in france which identified unauthorised silicone gel being used in the product.
Acción
The IMB recommends that:
Implanting surgeons / Implanting centres
• Identify women who were implanted with PIP silicone gel filled implants after 01 January 2001.
• Reassure them that there is no current evidence of health risk associated with the implants.
• Advise them that further information about the testing is available on the IMB, Therapeutic Goods Administration in Australia, Medicines And Healthcare products Regulatory Agency in UK and French Regulatory Agency AFSSAPs websites. (web addresses provided above).
GPs
Advise patients who are concerned about their PIP implants to consult their implanting surgeon/ implanting centres.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The potential supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
Acción
The IMB advises that:
• All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.
• If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local Covidien representative, who will be able to confirm if the product is authentic.
• If you identify that you have product that is counterfeit you should return any such affected product in your possession to the local Covidien representative and inform the IMB. Further Information: All adverse incidents relating to a medical device should be reported to the:
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@HPRA .ie
Website: www.HPRA .ie
Enquiries should be addressed to:
Local Covidien Office:
Deirdre O’Connor at: 087 8168519
Mark Gray at: 087 6538087
Covidien Ireland
Block G, 1st Floor
Loughlinstown
Dublin Please click here to download a pdf version of the safety Notice « View List Latest Information Provide Feedback Page Attachments - Advisory - Counterfeit Covidien Nellcor SpO2 RSS Feeds HPRA Notices RSS Feed
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
Acción
The IMB advises that:
• All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.
• If from your assessment you determine or suspect that you have product that is counterfeit identify, locate and quarantine all product to ensure it will not be used.
• If you identify that you have product that is counterfeit you should submit the information detailed in Appendix I to theHPRA (enforcement@hpra.ie). On receipt of this information the IMB will contact you to advise what further course of action is required.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Old style booms or spreader bars could fail and cause injury to the person being transferred.
Acción
Please review the attached FSN and complete the inspection as requested. Please discontinue the use of any hoists with the old style attachment where the boom locates onto two vertical pins on the motor/gearbox assembly (see FSN for additional information). Users should contact Murray’s Medical Equipment Ltd. to arrange for the supply of a replacement assembly, if required.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Bhm medical inc. has become aware that a number of hoists may have been fitted with an incorrect power cable on the control box.
Acción
The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all hoists affected by this field safety corrective action (FSCA).
The IMB advises that users:
• Follow the manufacturer’s recommendations as outlined in the attached field safety notice.
• Identify the affected hoists in your facility and contact the manufacturer to arrange for a power cable replacement.
• Remove any affected devices from service pending installation of the new power cable.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain level 1® normothermic iv fluid administration sets (models di-65hl, di-75 and di-150). in some cases, the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy, which could result in patient injury.
Acción
The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice.
Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly.
Users should also take care to:
• Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007.
• Contact the manufacturer to request a copy of the quick reference guide if required.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The acrobat 2000 spring-loaded arms could break. the acrobat 2000 spring arm has been used by a number of different manufacturers to support operating lights and monitors which have been placed on the market in ireland.
Acción
The IMB advises that users:
• Identify the affected spring arms in your facility and contact the appropriate manufacturer for further guidance.
• Follow the manufacturer’s recommendations as outlined in the associated field safety notices.
• Users are advised to exercise caution when moving or repositioning devices connected to these spring arms pending upgrade / inspection by the
manufacturer.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
Stolen non-sterile boston scientific endoscopy and urology/women’s health products are labelled as “sterile”.
Acción
The IMB advises that you:
• Check your inventory for the affected product
• Monitor all incoming shipments for the affected product
• If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Boston Scientific
• If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The zoll aed plus defibrillator may not deliver therapy.
Acción
1. Ensure that the relevant personnel in your organisation are made aware of this
issue.
2. Determine if you have purchased the affected serial numbers of this product,
AED Plus devices with serial numbers below X_ _ _200000.
3. If you have an affected device confirm that the recommended actions have been completed:
Ensure that the date when the batteries were installed in your device has been checked.
a. If batteries were installed more than three (3) years ago, replace the batteries
as soon as possible and add the label provided by Zoll showing the next
scheduled replacement date. Read and add the addendum incorporating this
information to the administrator’s guide that was provided by Zoll.
b. If batteries are not more than three (3) years old, add the label provided by
Zoll completed with the next scheduled replacement date. Read and add the
addendum, provided by Zoll, incorporating this information to the
administrator’s guide.