Natus Medical Incorporated: Ventilatory Effort Recorder
- Recalling firm
- NATUS MEDICAL INCORPORATED
- Product
- Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
- Reason
- The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with incorrect patient information from a subsequent study. The issue may also prevent studies from initiating recording successfully or may cause recordings to end prematurely, resulting in incomplete or unavailable diagnostic data and the potential need to repeat a patient study.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Italy, Portugal.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8b8dc78b-a8bd-43e3-b772-64e3f4cc69b1