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U.S. Department of Health and Human Services

Class 2 Device Recall Ascom Mobile Monitoring Gateway

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  Class 2 Device Recall Ascom Mobile Monitoring Gateway see related information
Date Initiated by Firm December 10, 2015
Create Date May 10, 2016
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-1638-2016
Recall Event ID 73578
510(K)Number K111215  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Code Information Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
Recalling Firm/
Manufacturer		 Ascom US, INC.
300 Perimeter Park Dr Ste D
Morrisville NC 27560-9703
For Additional Information Contact Remsey Lancaster
919-2342501
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSX and Original Applicant = ASCOM (SWEDEN) AB
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