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U.S. Department of Health and Human Services

Class 2 Device Recall 867098 Philips Network Firewall (Cisco ASA 5506 Firewall)

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  Class 2 Device Recall 867098 Philips Network Firewall (Cisco ASA 5506 Firewall) see related information
Date Initiated by Firm October 05, 2017
Date Posted March 03, 2018
Recall Status1 Terminated 3 on July 01, 2019
Recall Number Z-0850-2018
Recall Event ID 78849
510(K)Number K171801  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips Network Firewall (Cisco ASA 5506), Model # 867098

Code Information Serial Numbers for use in U.S.A.: JMX2030Y2B8 JMX2030Y2CR JMX2030Y2BN JMX2030Y2AY JMX2040Y2NZ JMX2022Y1U4 JMX2040Y2NU JMX2045Y2L0 JMX2030Y2D9 JMX2030Y2B1 JMX2035Y0XC JMX2035Y0XT JMX2030Y2DY JMX2035Y0XA JMX2040Y2R2 JMX2031Y0EV JMX2039Y1FZ JMX2030Y2BT JMX2030Y2EE JMX2030Y2DM JMX194840WA JMX2014419Y JMX201441AB JMX201441A4 JMX2014Z155 JMX2014Z15C JMX2014Z15L JMX2039Y1H7 JMX2039Y1H5 JMX2039Y1HR JMX2039Y1JM JMX2022Y194 JMX2018Z009 JMX2022Y15F JMX2040Y2QP JMX2030Y2PZ JMX2045Y2E4 JMX20184033 JMX2030Y2A8 JMX2039Y1GB JMX2040Y2P9 JMX2030Y2E6 JMX2030Y2EG JMX2022Y181 JMX2022Y1A7 JMX2040Y2QW JMX2030Y2B6   
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Kristen Philips
800-722-9377
Manufacturer Reason
for Recall		 Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. This failure will result in loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Philips sent an Urgent Recall Notice letter dated October 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a Philips representatives will contact affected customers to arrange for replacement of all affected units supplied by Philips. For questions contact your local Philips representative: Philips Customer Care Solution Center 800-722-9377.
Quantity in Commerce 332 units
Distribution US Nationwide
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 = MHX and Original Applicant = Philips Medizin Systeme Boeblingen GmbH
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