Recall Z-2139-2021 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
| Date | Jul 23, 2021 (initiated May 21, 2021) |
| Status | Open, Classified |
| Reason | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On May 21st the firm sent a letter to its customers with the following instructions: You can continue to use the CARESCAPE PDM with Masimo SET technology by completing the power down instructions below annually. 1. If the PDM is on a patient, provide alternate monitoring if needed, during the power down process. 2. Disconnect the PDM from the display device by removing the PDM from the mounting dock or by disconnecting the communication cable from the back of the PDM. 3. Open the battery door compartment and remove the battery (if present), for approximately 10 seconds. 4. Reinsert the battery |
| Quantity | 111,728 units |
| Distribution | worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Fij |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |