Recall Z-1725-2013 · MNR Ventilatory Effort Recorder
SagaTech Electronics, Inc.
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
| Date | Jul 11, 2013 (initiated May 8, 2008) |
| Status | Terminated |
| Reason | The outer jacket is receding away from the black sensor prematurely. |
| Root cause | Process design |
| Action | SagaTech Electronics Inc, sent a letter to their Customers dated May 2008. The letter identified the product the problem and the action needed to be taken by the customer. Please take particular attention when cleaning these sensors by holding the cable somewhere in the middle and clean towards each end. This should become standard practice with all sensors to prolong their lifespan. If you have further questions please call (403) 228-4214 ext. 234. |
| Quantity | 152 units 77 devices from lot 13367 and 75 devices from lot 13710 |
| Distribution | Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002159 | SNORE SAT RECORDER, MODEL SS41 Sagatech Electronics, Inc., Jun 28, 2002 |