Recall Z-1772-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the pat
| Date | Mar 28, 2017 |
| Status | Terminated |
| Reason | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. |
| Root cause | Under Investigation by firm |
| Action | On March 28, 2017, US consignees were sent an Urgent Medical Recall letter and Customer Reply and Order card. Delta family monitors running software version 10.0 in facilities that also have at least one Scio module will be downgraded to software version VF9.1 as a temporary solution Free of Charge. Draeger Medical Systems, Inc. is developing a new software version to resolve the issue (VF10.1). Once available, all Delta family monitors that were running software version VF10.0 will be upgraded with VF10.1 Free of Charge. For all other countries, the responsible local Draeger Sales and Servic |
| Quantity | 2,156 (total for all devices) |
| Distribution | Worldwide - US Nationwide distribution in the states of: AL, CA, GA, IL, LA, MA NY, OH, PA, TN, TX and VA and the countries of: AR AT BE BG BN BO BY CA CH CL CO CZ DE EG ES FI FR GB GR HR HU ID IE IL IN IT LT MX MY NL NO NP PA PE PK PL PT RO RS RU SA SE SK TH TR TW UG UZ VN ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152407 | Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc., Sep 23, 2015 |