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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare PIIC Classic Upgrade

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  Class 2 Device Recall Philips Healthcare PIIC Classic Upgrade see related information
Date Initiated by Firm November 25, 2015
Date Posted February 23, 2016
Recall Status1 Terminated 3 on September 06, 2017
Recall Number Z-0857-2016
Recall Event ID 72720
510(K)Number K102495  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips Healthcare PIIC Classic Upgrade, 866117
Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Code Information Software B.O
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Kelly Rector
978-659-2950
Manufacturer Reason
for Recall		 Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
FDA Determined
Cause 2		 Software Design Change
Action Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
Quantity in Commerce 5569 units
Distribution Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
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 MEDICAL SYSTEMS
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