Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,

FDA device recall Z-1538-2024 · posted 2024-04-12 · Open, Classified

Recall details

Recalling firm

Masimo Corporation

Reason for recall

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Action taken

On February 14, 2024 Masimo issued a "Urgent: Medical Device Recall Notice" via FedEx and US Mail to affected consignees. On February 29, 2024, Masimo issued an updated communication to provide additional information. Masimo's asked consignees to take the following actions: " 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 return of the affected part and serial number (s) for repair or replacement. " Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm 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 http://service.masimo.com. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023. Starting on 8/13/24, additional recall notices were sent identifying additional affected devices. Distributors were asked to identify their direct customers and provide them with the recall notice.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

DQA

Quantity affected

4978 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA

Date initiated

2024-02-15

Date posted

2024-04-12

Location

Irvine, CA

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