URGENT: MEDICAL DEVICE RECALL

Product Affected: 9210, 9847, 9849, 9895, 27977, 27978, 29097, 99025

Date Initiated: February 2024

Dear Valued Customer:
Masimo identified certain Rad-G® devices with power issues including powering off, power cycle loops, and powering off and on without pressing the power button. If the device powers off, it will impact the device’s ability to alarm. Masimo’s investigation identified an issue that can result in an unintentional change in the power state.

The Recall Notice applies to the specific Rad-G® devices with the part and Serial number(s) identified in this communication. Masimo received a total of 529 complaints related to this issue resulting in an occurrence rate of 3%.

Risk to Health:
If the device powers off unexpectedly, it could result in a loss of monitoring, which could potentially result in a delay in patient care because the device may fail to recognize a change in patient condition. If a change in a patient’s condition is not recognized through other monitoring or other means, a deterioration of the patient’s condition, including one resulting in a severe adverse outcome or death, could go undetected. Masimo received two reports of patient deaths while being monitored with Rad-G devices. Masimo has not determined whether these devices powered off unexpectedly.

No Impact to Other Products:
There is no impact on any other Masimo products.

ACTIONS TO BE TAKEN:

• Please assess your inventory to confirm if you have Rad-G devices listed in Attachment 2-part number(s) and serial number(s).
• If you identify affected Rad-G^® devices, please promptly remove them from use and follow the steps below.
• Contact Masimo Technical Services to request a return of the affected part and serial number (s) for repair or replacement.

ADDITIONAL INFORMATION:
Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by completing and returning the attached confirmation [email protected]

CONTACT TECHNICAL SERVICES:
Masimo’s Technical Services is available Monday through Friday 6:00 am -5:00 pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at https://service.masimo.com.

We are here to support you. If you have further questions or need assistance, please contact Masimo’s Technical Services at https://service.masimo.com.

ADVERSE REACTIONS OR QUALITY PROBLEMS:
Adverse reactions or quality problems experienced with this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program:

• Submit online: http://www.fda.gov/medwatch/report.htm
• Submit by regular mail or fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Masimo is committed to consistently providing high quality products and services to you, our customers. We apologize for any inconvenience this issue may have caused.

Sincerely,

Mathew Jimenez
SVP, Worldwide Quality & Compliance Masimo Corporation

Impacted Serial Numbers