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U.S. Department of Health and Human Services

Class 2 Device Recall Pulse Oximeter

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  Class 2 Device Recall Pulse Oximeter see related information
Date Initiated by Firm March 13, 2013
Date Posted April 29, 2013
Recall Status1 Terminated 3 on June 10, 2015
Recall Number Z-1187-2013
Recall Event ID 64812
Product Classification Oximeter - Product Code DQA
Product Rad-8 Pulse Oximeters

The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Code Information Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194 
Recalling Firm/
Manufacturer		 Masimo Corporation
Forty Parker
Irvine CA 92618
For Additional Information Contact
949-297-7000
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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. . .
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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