Z-2175-2011

Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information...

Name: Z-2175-2011 Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information...
Creator: Philips Healthcare Inc.
Published: 2011-03-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-03-16 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue... on 2011-03-16. The reason FDA records is "Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2175-2011
Status: Terminated
Initiated: 2011-03-16
Posted: 2011-05-10
Terminated: 2020-08-13
Recalling firm: Philips North America LLC
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
Product code: NSX
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: versions D.03, E.0, or E.01 of the software

Product code NSX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)