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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue Clinical Information Portfolio

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  Class 2 Device Recall Philips IntelliVue Clinical Information Portfolio see related information
Date Initiated by Firm March 16, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on August 13, 2020
Recall Number Z-2175-2011
Recall Event ID 58182
510(K)Number K992636  K100272  
Product Classification patient data system - Product Code NSX
Product Philips IntelliVue Clinical Information Portfolio software as follows:
865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
Code Information versions D.03, E.0, or E.01 of the software
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Sushil Amin
978-659-7199
Manufacturer Reason
for Recall		 Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare notified accounts on 3/16/11 via the Urgent Medical Device Correction Notification. Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. All customers potentially affected by this issue will receive the software correction as part of the field action.
Quantity in Commerce 387 units
Distribution Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
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 = NSX and Original Applicant = HEWLETT-PACKARD CO.
510(K)s with Product Code = NSX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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