Masimo Corporation Forty Parker Recalls
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rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
Masimo sent an Urgent Product Recall letter on October 28, 2015, to all affected customers to inform them that Masimo has identified specific lots of sensors that were manufactured with incompatiable configurations. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete the tracking/verification form and email to Masimo. Customers with questions were instructed to contact Masimo Technical Services at http://Service.Masimo.com. For questions regarding this recall call 949-297-7000.
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
An "Urgent: Advisory Notice," dated 09/30/2014, was sent to customers. The letter informed customers of the problem identified and the actions to be taken. Customers were instructed to evaluate their inventory of Oximetry Cable(s) using the following method: Use the Oximetry Cable to take a SpO2 measurement on a healthy individual with an expected SpO2 value above 90% or review SpO2 measurements take with the Oximetry Cable and verify that measurement results were consistent with expected SpO2 values. If the SpO2 measurement(s) is consistent with expected SpO2 value, the Oximetry Cable is not affected and can continue to be used. Customers are instructed to complete and return Attachment 2, Tracking/Verification Form, to Masimo in order to document that the Oximetry Cable(s) is functioning as intented. If the assessment results in SpO2 measurement that is not consistent with expected SpO2 value, then the Oximetry Cable should be removed from service, segregated and returned to Masimo. Customers are instructed to call 1-800-326-4890 and select option 2 for Technical Services. Customers are to determine with Technical Services whether they will return the affected Oximetry Cable(s) to Masimo for replacement or refund. If returning for replacement customers are suppose to obtain a Return Material Authorization Number (RMA number).
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).
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.
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. . .