Renaissance Respiratory

Philips issues recall for certain sleep therapy masks

Tue, 06 Sep 2022 00:00:00 +0000

Since its inception, Renaissance Respiratory has sought to raise the bar of excellence. Because of that, we are following through with a recall issued by Philips for certain sleep therapy masks.

The recall from the Philips reads as follows:

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body

Pittsburgh, Pennsylvania – Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:

Pacemakers

Implantable cardioverter defibrillators (ICD)

Neurostimulators

Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)

Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)

Aneurysm clips

Embolic coils

Intracranial aneurysm intravascular flow disruption devices

Metallic cranial plates, screws, burr hole covers, and bone substitute devices

Metallic splinters in the eye

Ocular implants (e.g., glaucoma implants, retinal implants)

Certain contact lenses with metal

Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)

Magnetic denture attachments

Metallic gastrointestinal clips

Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)

Implantable ports and pumps (e.g., insulin pumps)

Hypoglossal nerve stimulators

Devices labeled as MR (Magnetic Resonance) unsafe

Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained.

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnetic clips with a field strength of less than 400 mT are used in the mask.* With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include:

More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of September 2022, Philips Respironics has received 16 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options. Patients may also contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice.

Any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

* The application of Philips Respironics’ magnetic headgear clips and straps - according to the previous, as well as the current updated instructions and labeling - complies with the guidelines from the International Commission of Non-Ionizing Radiation Protection (ICNIRP), as well as the ISO 14117:2019-09 standard, for use of magnetic elements in proximity of implanted medical devices.

An FAQ can be found here.

KEGO Corporation issues recall for SoClean 2

Mon, 05 Sep 2022 00:00:00 +0000

Since its inception, Renaissance Respiratory has sought to raise the bar of excellence. Because of that, we are following through with a recall issued by KEGO Corporation for the SoClean 2.

The letter we received from KEGO Corporation reads as follows:

Recall Notice – Labelling Amendment
May 19, 2022
Dear Sir/Madame:

Re: SoClean 2 Labelling Amendment in Canada

We are writing to notify you of a recent important change to the label and instructions for use applicable to the SoClean 2 device (Medical Device Licence No. 100197) in Canada.

We are notifying SoClean 2 users of the following labelling changes, which were approved by Health Canada in June 2021:

Running the SoClean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms. Independent lab testing with SoClean 2 demonstrates that, when set at the 12-minute cycle time duration, it kills 99.9% of the following microorganisms comprised of the following bacteria: Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus epidermidis, and yeast: Candida albicans. Previous labelling did not specify to run SoClean for a 12-minute cycle.

SoClean 2 is not an Automated PAP disinfecting system but rather an Automated Supplemental PAP Maintenance Device.

Users must follow the CPAP-manufacturer’s instructions for cleaning their PAP accessories. The SoClean 2 is intended for use as a supplement to that cleaning.

The SoClean 2 is intended for use with single-user, personal at-home-use PAP device accessories.

This labeling amendment was made in consultation with Health Canada. Health Canada considers the re-labelling to be a recall, so we are writing to you today to notify you of the action taken and to provide you with the following link to the updated label and instructions for use for the SoClean 2: SoClean2 CA IFU. This notice applies only to Canada.

No action is required in connection with the SoClean 2 device itself and it can continue to be used safely and effectively in accordance with the updated label and instructions for use linked above.

If you have sold or otherwise distributed the SoClean 2 device, please forward this communication to your customers with instructions that they do the same. In addition, please acknowledge your receipt of this notice by email (asommers@kegocorp.com) or by fax (1-866-294-5346).

Thank you very much for your attention to this matter. As KEGO no longer distributes the SoClean 2, any further questions may be directed to SoClean directly at (800) 916-4577 or info@soclean.com.

Sincerely,

Amie Sommers
HR/Quality Manager, Customer Care Manager
KEGO Corporation
asommers@kegocorp.com 866-862-7328 ext. 215

Mailing: 1064 Hargrieve Road, Unit C, London, ON N6E 1P5 | Warehouse: 4350 Castleton Road, Unit 3/4, London, ON N6N 0A3
Tel: 866.862.7328 Fax: 866.294.5346 www.kegocorp.com

Philips issues recall for respiratory devices

Mon, 14 Jun 2021 00:00:00 +0000

Since its inception, Renaissance Respiratory has sought to raise the bar of excellence. Because of that, we are following through with a recall issued by Philips for certain respiratory devices.

The recall from Philips reads as follows:

In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

We recognize the importance of your relationship with your patients. You play a crucial role in supporting them through the remediation process. At Philips, we are committed to supporting you throughout the remediation and have a range of tools and resources to help.

Thank you for your patience as we work to restore your trust.