Recall Z-0319-2027 ยท MNR Ventilatory Effort Recorder
NATUS MEDICAL INCORPORATED
Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
| Date | Oct 30, 2026 (initiated Sep 29, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | An Urgent Medical Device Field Correction notification letter was sent to customers beginning 9/29/26. ACTION: " Review the serial numbers in this notice and identify any affected devices that are currently in your possession. " Immediately cease use of the affected product and quarantine until you receive further instructions from Natus for correcting the affected device(s). " Review all studies recorded on affected Embletta MPR devices to verify that patient information is correctly associated with the corresponding study and that the study data are complete, accurate, and attributable to t |
| Quantity | 288 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Italy, Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122516 | EMBLETTA MPR Embla Systems, Feb 21, 2013 |