Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive

FDA device recall Z-1187-2013 · posted 2013-04-29 · Terminated

Recall details

Recalling firm

Masimo Corporation

Reason for recall

Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

Action taken

Masimo Corporation sent an Urgent Recall Notification letter dated March 8, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. 1.Customers were instructed to please promptly remove all Rad-8 device(s) from use and your inventory and segregate these devices. 2. Please call 1-800-326-4890 and select option 2 for Technical Services. Determine with Technical Services whether you will return the affected device(s) to Masimo for repair or if eligible, receive a repair kit. If you will return the device(s) for repair, obtain a Return Material Authorization Number (RMA number). 3. Complete the Tracking/Verification Form in Attachment 2 and fax it to Masimo at 1-949-297-7700, even if you do not have or intend to use the affected device(s). 4. If you are eligible and intend to repair units onsite fax the completed original form in Attachment 2 to Masimo at 1-949-297-7700. 5. If you have elected to return the affected device(s), and have an RMA number include the completed original Form in Attachment 2 with the returned device(s) and indicate the RMA number on the outside of the return-shipping box. We apologize for the inconvenience. Please be assured that Masimo is committed to consistently providing high quality products and services to you, our customers. We thank you for your patience and cooperation while we actively work to resolve this issue. . .

Root cause

Device Design

Status

Terminated

Product code

DQA

Quantity affected

42,908 units

Distribution

Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.

Date initiated

2013-03-13

Date posted

2013-04-29

Date terminated

2015-06-10

Location

Irvine, CA