URGENT, MEDICAL DEVICE FIELD ACTION

Products affected: 4470-MY, 4470-9-MY, 4471-MY, 4471-9-MY, 4475-MY, 4475-9-MY, 4476-9-MY

July 2025

Dear Valued Customer:
Masimo identified certain parts and lot numbers of RD SET Cabled Sensors were manufactured without a required piece of insulation tape. A sensor without the insulation tape can experience an internal short and result in a “replace sensor” message on the Masimo monitor. This could also result in an audible alarm on the monitor if the short occurs during monitoring. Other compatible monitors will provide comparable messages and an alarm.
The Customer Notice applies to the specific RD SET Cabled Sensor part numbers and lot number(s) identified in this communication.

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:
There are no health consequences associated with this issue. The issue may render impacted sensors unusable when connected to both Masimo and other compatible monitors. An internal short does not impact the electrical isolation between the sensor’s internal electronic components and the patient/caregiver.
The issue has been addressed, and currently manufactured sensors are not impacted. Please follow the steps defined in the “Actions to be taken by Customer” section of this notice.

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

ACTIONS TO BE TAKEN:

• Please assess your inventory to identify if you have impacted RD SET Cabled Sensors identified in this communication and included in the mailing sent out by Masimo to your facility. Complete Attachment 1 of the mailing, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575.
• Contact Masimo Customer Support to request return of the affected part and lot number (s) for replacement.

Masimo’s Customer Support is available 24 hours a day, seven days a week. Local contact information can be found at https://www.mymasimo.com/contact-us/ You can also email us at customercare@masimo.com.

Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax. 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 Part ID