Recall Z-1538-2024
Masimo Corporation · initiated February 15, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Codes / lots: UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000066282 6000066408 6000066411 6000066442 6000066476 6000066577 6000066623 6000066856 6000067119 6000067120 6000067122 6000067134 6000067140 6000067142 6000067145 6000067150 6000067151 6000067162 6000067163 6000067167 6000067168 6000067170 6000067173 6000067175 6000067176 6000067177 6000067178 6000067179 6000067180 6000067182 6000067183 6000067185 6000067186 6000067188 6000067192 6000067193 6000067194 6000067196 6000067198 6000067201 6000067202 6000067207 6000067211 6000067224 6000067225 6000067235 6000067241 6000067245 6000067246 6000067247 6000067252 6000067256 6000067269 6000067272 6000067278 6000067293 6000067300 6000067309 6000067311 6000067312 6000067314 6000067345 6000067356 6000067357 6000067360 6000067366 6000067367 6000067418 6000067443 6000067446 6000067472 6000067475 6000067482 6000067484 6000067486 6000067496 6000067515 6000067552 6000067563 6000067584 6000067609 6000067625 6000067626 6000067629 6000067642 6000067658 6000067660 6000067662 6000067663 6000067673 6000067679 6000067680 6000067686 6000067689 6000067695 6000067701 6000067702 6000067710…
Reason for recall
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-1538-2024
- Initiated
- February 15, 2024
- Posted by FDA
- April 12, 2024
- Product code
- DQA – Oximeter
- Quantity
- 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, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia…
- Recalling firm
- Masimo Corporation, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1536-2024 Class II | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 02/15/2024Open, Classified |
| Z-1537-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 02/15/2024Open, Classified |
| Z-1539-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 02/15/2024Open, Classified |