Recall Z-1536-2024
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 with temperature (W/Sensor), REF:9210, Rx Only,
Codes / lots: UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 6000084005 6000084009 6000084010 6000084012 6000084013 6000084015 6000084016 6000084038 6000084046 6000084052 6000084057 6000084059 6000084060 6000084064 6000084067 6000084071 6000084080 6000084134 6000084140 6000084165 6000084175 6000084184 6000084192 6000084196 6000084197 6000084200 6000084201 6000084202 6000084207 6000084266 6000084278 6000084279 6000084280 6000084282 6000084284 6000084285 6000084286 6000084287 6000084288 6000084289 6000084296 6000084299 6000084306 6000084310 6000084313 6000084314 6000084315 6000084317 6000084318 6000084319 6000084321 6000084325 6000084326 6000084328 6000084329 6000084331 6000084332 6000084398 6000084410 6000084418 6000084424 6000084478 6000084481 6000084512 6000084546 6000084553 6000084554 6000084556 6000084562 6000084565 6000084566 6000084580 6000084583 6000084590 6000084591 6000084592 6000084593 6000084594 6000084596 6000084598 6000084600 6000084602 6000084604 6000084609 6000084610 6000084615 6000084618 6000084620 6000084624 6000084625 6000084627 6000084629 6000084633 6000084634 6000084635 6000084636 6000084637 6000084638…
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-1536-2024
- Initiated
- February 15, 2024
- Posted by FDA
- April 12, 2024
- Product code
- DQA – Oximeter
- Quantity
- 443 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-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-1538-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, 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 |