Recall Z-1926-2019 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Infinium Medical, Inc
CLEO Patient Monitor /Tranquility VS Patient Monitor
| Date | May 31, 2019 |
| Status | Open, Classified |
| Reason | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. |
| Root cause | Labeling False and Misleading |
| Action | Infinium Medical, Inc. notified customers on about 05/31/2019 via "URGENT: MEDICAL DEVICE RECALL" letter sent through email and certified letter. Instructions included to remove all temperature modules from the CLEO & Tranquility VS Patient Monitors and destroyed. They were also requested to complete and return the Medical Device Recall Return Response Form to QARA@infiniummedical.com. Once the response form is received, a new IFU and standalone temperature monitor will be provided. Questions and comments can be sent to Mr. George Anello during regular business hours (8:00 AM - 04:30 |
| Quantity | 95 devices |
| Distribution | Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142244 | CLEO PATIENT MONITOR Infinium Medical, Feb 6, 2015 |