Recall Z-1638-2016 ยท MSX System, Network And Communication, Physiological Monitors
Ascom US, INC.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
| Date | Dec 10, 2015 |
| Status | Terminated |
| Reason | Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored. |
| Root cause | Software design |
| Action | On January 4, 2016 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 2016, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions |
| Quantity | 319 |
| Distribution | CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111215 | ASCOM MOBILE MONITORING GATEWAY (MMG) Ascom (Sweden) AB, Jul 5, 2011 |