CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
FDA device recall Z-2139-2021 · posted 2021-07-23 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
- Action taken
- 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 and reconnect the PDM to the display device
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 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, Colo
- Date initiated
- 2021-05-21
- Date posted
- 2021-07-23
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |